Alloy, Metal, Base
FDA product code EJH · Class II (moderate risk) · 21 CFR 872.3710 · Dental
153510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Aalba Dent, Inc. 18
- Jeneric Ind. 12
- Jeneric/Pentron, Inc. 6
- Austenal Dental, Inc. 6
- Williams Gold Refining Co., Inc. 5
- North American Alloys, Inc. 5
- Neirynck & Vogt NV 5
- Dentsply Intl. 5
- Dental Alloy Products, Inc. 5
- American Dent-All, Inc. 5
- Matech, Inc. 4
- Argen Precious Metals, Inc. 4
- C.K. International Trading 4
- Dentauraum, Inc. 4
- Ivoclar North America, Inc. 4
- Ivoclar Vivadent, Inc. 3
- Degussa Dental, Inc. 3
- Austenal, Inc. 2
- Deringer-Ney, Inc. 2
- C.Vaupel Dental, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K123929 | Begopal+EJH · Abbreviated | Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO | 03/14/2013SE |
| K040180 | Continum VEJH · Traditional | Aalba Dent, Inc. | 03/04/2004SE |
| K040179 | ContinumEJH · Traditional | Aalba Dent, Inc. | 03/03/2004SE |
| K033356 | Verasoft EsEJH · Traditional | Aalba Dent, Inc. | 12/30/2003SE |
| K033045 | Dream Bond, Dreamcast Chrome, Dreamcast V, Dream Flexicast, Dream LithecastEJH · Traditional | American Green Dent. Mfg, Inc. | 12/23/2003SE |
| K032136 | Wirobond CEJH · Traditional | Bego U.S.A. | 09/04/2003SE |
| K031627 | Nano-TicrownEJH · Traditional | Nano-Write Corp. | 06/11/2003SE |
| K030632 | PD Casta-HEJH · Traditional | Mountain Medico, Inc. | 05/07/2003SE |
| K030416 | Ceracast-VEJH · Traditional | Mountain Medico, Inc. | 04/14/2003SE |
| K030161 | SuperbondEJH · Traditional | American Dent-All, Inc. | 03/17/2003SE |
| K024214 | Kavo Everest TitanblankEJH · Traditional | Kavo America | 03/12/2003SE |
| K023499 | Gold Core PlusEJH · Traditional | Pentron Laboratory Technologies | 01/13/2003SE |
| K023502 | Jewel Cast PlusEJH · Traditional | Pentron Laboratory Technologies | 12/18/2002SE |
| K023477 | BioloyEJH · Traditional | Neirynck & Vogt NV | 12/13/2002SE |
| K021971 | CeraloyEJH · Traditional | Neirynck & Vogt NV | 08/01/2002SE |
| K021969 | ChroloyEJH · Traditional | Neirynck & Vogt NV | 07/30/2002SE |
| K021968 | Ceraloy SolderEJH · Traditional | Neirynck & Vogt NV | 07/26/2002SE |
| K021965 | Chroloy SolderEJH · Traditional | Neirynck & Vogt NV | 07/26/2002SE |
| K020253 | 4 All (DW286A)EJH · Traditional | Ivoclar Vivadent, Inc. | 04/17/2002SE |
| K020898 | D.Sign 15 (DW286 B)EJH · Traditional | Ivoclar Vivadent, Inc. | 03/29/2002SE |
| K020183 | Pisces Plus (DW286 C)EJH · Traditional | Ivoclar Vivadent, Inc. | 03/13/2002SE |
| K020062 | XerafitEJH · Traditional | Metalor Technologies USA | 02/14/2002SE |
| K011706 | Flexicast PrimeEJH · Traditional | American Dent-All, Inc. | 08/06/2001SE |
| K011705 | SupremcastEJH · Traditional | American Dent-All, Inc. | 08/03/2001SE |
| K010381 | D.Sign 30EJH · Traditional | Ivoclar North America, Inc. | 03/06/2001SE |
| K010069 | Durabond Non-Precious Ceramic AlloyEJH · Traditional | Matech, Inc. | 02/15/2001SE |
| K003387 | Aurofilm NPEJH · Traditional | Metalor Dental USA Corp. | 01/09/2001SE |
| K003509 | FlexicastEJH · Traditional | American Dent-All, Inc. | 01/02/2001SE |
| K003039 | Gold Core IIEJH · Traditional | Jeneric/Pentron, Inc. | 12/05/2000SE |
| K003037 | Jewel Cast IIIEJH · Traditional | Jeneric/Pentron, Inc. | 12/05/2000SE |
| K002302 | Super 14EJH · Traditional | Dental Alloy Products, Inc. | 09/26/2000SE |
| K002300 | Super 6EJH · Traditional | Dental Alloy Products, Inc. | 09/26/2000SE |
| K002301 | Super 12EJH · Traditional | Dental Alloy Products, Inc. | 09/08/2000SE |
| K002299 | Super 3EJH · Traditional | Dental Alloy Products, Inc. | 09/08/2000SE |
| K002298 | Super 1EJH · Traditional | Dental Alloy Products, Inc. | 08/24/2000SE |
| K001798 | DC TitanEJH · Traditional | Austenal, Inc. | 07/31/2000SE |
| K001383 | Supremcast VEJH · Traditional | American Dent-All, Inc. | 07/05/2000SE |
| K001269 | Dentalmatic Ti Prosthesis and Dentalmatic Ti-A ProstheticEJH · Traditional | Dentalmatic Technologies, Inc. | 06/21/2000SE |
| K000981 | Ceramix Ez Cast, Ceramix Ez Cast Solder, Ceramix Ez Cast FluxEJH · Traditional | C-Mix | 06/13/2000SE |
| K993572 | Ceradium V Non-Precious Ceramic AlloyEJH · Traditional | Matech, Inc. | 12/13/1999SE |
| K992881 | Hi Bond Non-Precious Ceramic AlloyEJH · Traditional | Matech, Inc. | 11/19/1999SE |
| K993344 | P10 SpecialEJH · Traditional | North American Alloys, Inc. | 11/15/1999SE |
| K992705 | Ceradium Non-Precious Ceramic AlloyEJH · Traditional | Matech, Inc. | 09/22/1999SE |
| K990235 | D-Sign Vi (R&D Project DW266#9)EJH · Traditional | Ivoclar North America, Inc. | 03/01/1999SE |
| K990182 | D-Sign V (R&D Project DW267#17)EJH · Traditional | Ivoclar North America, Inc. | 03/01/1999SE |
| K984164 | Jelbond NPEJH · Traditional | Jelenko Co. | 12/29/1998SE |
| K982094 | Verabond 2EJH · Traditional | Aalba Dent, Inc. | 07/22/1998SE |
| K972971 | NPG + 2EJH · Traditional | Aalba Dent, Inc. | 01/05/1998SE |
| K973569 | Sowell Nickel-Chrome-Molybdenum AlloyEJH · Traditional | C.K. International Trading | 12/11/1997SE |
| K973568 | Sowell Nickel-Chrome Non-Precious Metal AlloyEJH · Traditional | C.K. International Trading | 12/11/1997SE |
| K973567 | Sowell Cobalt-Chrome Metal AlloyEJH · Traditional | C.K. International Trading | 12/11/1997SE |
| K973566 | Sowell Patented Non-Precious Metal AlloyEJH · Traditional | C.K. International Trading | 12/08/1997SE |
| K973265 | Verabond 2VEJH · Traditional | Aalba Dent, Inc. | 10/16/1997SE |
| K972607 | PlatalloyEJH · Traditional | Aalba Dent, Inc. | 10/10/1997SE |
| K972118 | Vera PDNEJH · Traditional | Aalba Dent, Inc. | 08/15/1997SE |
| K970205 | Vitallium 2000 Alloy; Vitallium 2000 Plus Alloy; Cobalt Chrome Casting AlloyEJH · Traditional | Austenal, Inc. | 04/21/1997SE |
| K970827 | PreciseEJH · Traditional | Allan Schulman,D.D.S., M.S. | 04/16/1997SE |
| K963891 | RX 96EEJH · Traditional | Jeneric/Pentron, Inc. | 11/19/1996SE |
| K961720 | Ceramco Crowns and BridgesEJH · Traditional | Eric S. Small, Dds | 07/18/1996SE |
| K953594 | VulcanEJH · Traditional | Cmp Industries, LLC | 09/05/1995SE |
| K952870 | Remanium: CS & G-SoftEJH · Traditional | Dentauraum, Inc. | 07/27/1995SE |
| K952867 | Remanium:Gm 700, GM 380, GM 800, GFHEJH · Traditional | Dentauraum, Inc. | 07/27/1995SE |
| K952866 | Rematitan TitaniumEJH · Traditional | Dentauraum, Inc. | 07/27/1995SE |
| K952865 | Remanium: 200,CS, 380, and CDEJH · Traditional | Dentauraum, Inc. | 07/26/1995SE |
| K950894 | Surefire Pf+ (High Palladium Dental Casting Alloy for Porcelain Applications)EJH · Traditional | Argen Precious Metals, Inc. | 03/31/1995SE |
| K950951 | Neocast C, V, SEJH · Traditional | Neodontics, Inc. | 03/23/1995SE |
| K945714 | Verabond IIIEJH · Traditional | Aalba Dent, Inc. | 12/29/1994SE |
| K945713 | Verabond IIEJH · Traditional | Aalba Dent, Inc. | 12/29/1994SE |
| K945712 | Verabond VEJH · Traditional | Aalba Dent, Inc. | 12/29/1994SE |
| K926165 | Ceramco Crowns and BridgesEJH · Traditional | Asap Dental Lab, Ltd. | 03/31/1994SE |
| K940749 | LPG 5/10, LPG 10/5, LPG 10/15 and LPG 15/10EJH · Traditional | Aalba Dent, Inc. | 03/28/1994SE |
| K932893 | Vident 500 Alloy and Vident 550 Be AlloyEJH · Traditional | Vident | 03/28/1994SE |
| K934758 | R2+EJH · Traditional | Jeneric/Pentron, Inc. | 02/18/1994SE |
| K935972 | Argeloy N.P. (V) (Non-Precious Dental Alloy for Procelain Application)EJH · Traditional | Argen Precious Metals, Inc. | 01/26/1994SE |
| K935829 | Argeloy Partial (Non-Precious)EJH · Traditional | Argen Precious Metals, Inc. | 01/26/1994SE |
| K924716 | Nico Dental AlloyEJH · Traditional | Co-Nick Alloys (India) , Ltd. | 01/21/1994SE |
| K934768 | Argelite 81SF+EJH · Traditional | Argen Precious Metals, Inc. | 12/10/1993SE |
| K922954 | R1, R2, and R1+EJH · Traditional | Jeneric/Pentron, Inc. | 07/22/1993SE |
| K926347 | Duceranium UEJH · Traditional | Degussa AG | 05/27/1993SE |
| K925579 | Verasoft Casting AlloyEJH · Traditional | Aalba Dent, Inc. | 03/16/1993SE |
| K922790 | Degucast 40EJH · Traditional | Degussa AG | 12/03/1992SE |
| K915250 | Wil-Pds & Wil-Pdi Casting AlloysEJH · Traditional | Wilde-USA, Inc. | 04/21/1992SE |
| K920561 | DW242-07 Non-Precious Alloy F/ Porcelain Fus. Met.EJH · Traditional | Ivoclar North America, Inc. | 03/02/1992SE |
| K915249 | Vera PDS & Vera PdiEJH · Traditional | Aalba Dent, Inc. | 03/02/1992SE |
| K915248 | LPG Casting AlloyEJH · Traditional | Aalba Dent, Inc. | 12/30/1991SE |
| K915247 | NPG III Casting AlloyEJH · Traditional | Aalba Dent, Inc. | 12/30/1991SE |
| K913857 | Rocatec(R) -PlusEJH · Traditional | Espe GmbH (Us) | 12/16/1991SE |
| K911323 | Flux-N-AllEJH · Traditional | Precident Corp. | 09/30/1991SE |
| K905034 | HD-4 Crown & Bridge AlloyEJH · Traditional | Ho Dental Co., Inc. | 09/05/1991SE |
| K901552 | (CP) Titanium and TI6AI-4V Alloy for Fixed ProstheEJH · Traditional | Nobelpharma USA, Inc. | 06/24/1991SE |
| K911821 | Thermabond Supercast NP or Thermabond SupercastEJH · Traditional | Dentecon, Inc. | 05/30/1991SE |
| K903538 | Wiron 99 Dental Casting AlloyEJH · Traditional | Leach and Dillon Co., Inc. | 03/15/1991SE |
| K903008 | Vident 90 Alloy and Vident 95 AlloyEJH · Traditional | Vident | 09/06/1990SE |
| K900117 | Stellite Cobalt/Chromium Base Metal AlloyEJH · Traditional | D.C. Dental Specialties | 04/02/1990SE |
| K896501 | Tech Star Dental Casting Alloys (Non-Precious)EJH · Traditional | Leach and Dillon Co., Inc. | 02/09/1990SE |
| K894085 | Talladium Tilite Ceramic AlloyEJH · Traditional | Talladium, Inc. | 12/20/1989SE |
| K884257 | LeviniumEJH · Traditional | Ticomet Engineering & Consulting | 12/22/1988SE |
| K882170 | RX AspenEJH · Traditional | Jeneric/Pentron, Inc. | 06/17/1988SE |
| K880875 | Vitallium Equipoise AlloyEJH · Traditional | Austenal Dental, Inc. | 04/07/1988SE |
| K873661 | Chrome-Cobalt Base Dental AlloyEJH · Traditional | North American Alloys, Inc. | 11/16/1987SE |
| K864826 | A-Sp Alloy (Silver-Palladium Crown & Bridge Alloy)EJH · Traditional | Austenal Dental, Inc. | 02/10/1987SE |
| K863782 | NPG Nonprecious Crown and Bridge AlloyEJH · Traditional | Aalba Dent, Inc. | 11/07/1986SE |
| K862930 | Perfect OneEJH · Traditional | North American Alloys, Inc. | 10/24/1986SE |
| K862822 | Rexillium N. B. F.EJH · Traditional | Jeneric Ind. | 09/02/1986SE |
| K862499 | UltracastEJH · Traditional | Ultratek | 08/18/1986SE |
| K862870 | Resistal PEJH · Traditional | Degussa Dental, Inc. | 08/15/1986SE |
| K862667 | Cobalt, 29.5% Chromium Alloy Dental Bake-On AlloyEJH · Traditional | Austenal Dental, Inc. | 07/31/1986SE |
| K862417 | NICKEL,20% Chromium Porcelain Fused to Metal AlloyEJH · Traditional | Austenal Dental, Inc. | 07/03/1986SE |
| K861820 | Biosil FEJH · Traditional | Degussa Dental, Inc. | 06/13/1986SE |
| K861787 | Biosil HEJH · Traditional | Degussa Dental, Inc. | 05/21/1986SE |
| K860437 | Partial Denture AlloyEJH · Traditional | Dentsply Intl. | 03/17/1986SE |
| K860217 | NCM - Alpha Alloy (Dental Bake-On Alloy)EJH · Traditional | Austenal Dental, Inc. | 03/17/1986SE |
| K854738 | Spartan SolderEJH · Traditional | Williams Gold Refining Co., Inc. | 03/06/1986SE |
| K854878 | H40 Base Metal AlloyEJH · Traditional | Jeneric Ind. | 01/30/1986SE |
| K854495 | Gresco N.P. Dental AlloyEJH · Traditional | Gresco Products, Inc. | 12/27/1985SE |
| K854285 | GDC 1453 Casting AlloyEJH · Traditional | Deringer-Ney, Inc. | 12/27/1985SE |
| K853845 | Alloy BEJH · Traditional | North American Alloys, Inc. | 11/19/1985SE |
| K852895 | Ceramic Alloy No. DW 179EJH · Traditional | Williams Gold Refining Co., Inc. | 10/21/1985SE |
| K853498 | Perfect 10EJH · Traditional | North American Alloys, Inc. | 09/27/1985SE |
| K851515 | Heraenium CaEJH · Traditional | Heraeus Dental Gold Corp. | 09/23/1985SE |
| K850084 | Trindium-Dental MaterialEJH · Traditional | Trindium Corp. of America | 07/08/1985SE |
| K851569 | Vera Bond Non Percious Ceramic AlloyEJH · Traditional | Aalba Dent, Inc. | 05/29/1985SE |
| K844497 | Austenal A-79 Crown & Bridge Casting AlloyEJH · Traditional | Austenal Dental, Inc. | 02/27/1985SE |
| K844123 | RX CbyEJH · Traditional | Jeneric Ind. | 01/09/1985SE |
| K844122 | RX CBGEJH · Traditional | Jeneric Ind. | 01/09/1985SE |
| K842551 | Base Metal AlloyEJH · Traditional | Dentsply Intl. | 08/02/1984SE |
| K842377 | MS Nonprecious Crown & Bridge AlloyEJH · Traditional | Dental Ventures of America, Inc. | 07/31/1984SE |
| K841290 | Steldent - Dental AlloyEJH · Traditional | Eriez | 06/27/1984SE |
| K840562 | Rex VEJH · Traditional | Jeneric Ind. | 04/13/1984SE |
| K834560 | Vitex P.D.AEJH · Traditional | Jeneric Ind. | 02/27/1984SE |
| K833512 | Partial Denture AlloyEJH · Traditional | Dentsply Intl. | 12/27/1983SE |
| K833143 | Rexillium IIIEJH · Traditional | Jeneric Ind. | 12/08/1983SE |
| K833145 | ZenithEJH · Traditional | Jeneric Ind. | 11/28/1983SE |
| K833144 | Rex AlloyEJH · Traditional | Jeneric Ind. | 10/28/1983SE |
| K823008 | NovarexEJH · Traditional | Jeneric Ind. | 11/03/1982SE |
| K822957 | PurcastEJH · Traditional | J. Aderer, Inc. | 10/26/1982SE |
| K822947 | NeptuneEJH · Traditional | Jeneric Ind. | 10/26/1982SE |
| K822948 | RX BiocastEJH · Traditional | Jeneric Ind. | 10/22/1982SE |
| K822896 | CavidryEJH · Traditional | Parker Laboratories, Inc. | 10/22/1982SE |
| K820328 | Nickel-Based Dental Casting AlloyEJH · Traditional | Dentsply Intl. | 03/02/1982SE |
| K820049 | CerilliumEJH · Traditional | Jelrus Technical Products Corp. | 02/22/1982SE |
| K813243 | Ceral-Base Metal AlloyEJH · Traditional | Sillard Products, Inc. | 12/31/1981SE |
| K811258 | Base Metal AlloyEJH · Traditional | Dentsply Intl. | 07/23/1981SE |
| K811013 | Summar Non-Precious, Ceramic AlloyEJH · Traditional | Shofu Dental Corp. | 06/26/1981SE |
| K811407 | BA-93EJH · Traditional | Deringer-Ney, Inc. | 06/16/1981SE |
| K810611 | Fulcast/Summit Casting AlloyEJH · Traditional | C.Vaupel Dental, Inc. | 03/24/1981SE |
| K810594 | Crystalloy-PEJH · Traditional | Shofu Dental Corp. | 03/24/1981SE |
| K810521 | Co-Span 13.5 Casting AlloyEJH · Traditional | C.Vaupel Dental, Inc. | 03/17/1981SE |
| K800371 | Will Ceram Lite-Cast BEJH · Traditional | Williams Gold Refining Co., Inc. | 02/28/1980SE |
| K780642 | Litecast SolderEJH · Traditional | Williams Gold Refining Co., Inc. | 05/03/1978SE |
| K780090 | Dental AlloyEJH · Traditional | Krupp International, Inc. | 03/14/1978SE |
| K772256 | Crown & Bridge AlloyEJH · Traditional | Johnson & Johnson Professionals, Inc. | 01/03/1978SE |
| K771081 | Litecast CeramicEJH · Traditional | Williams Gold Refining Co., Inc. | 06/24/1977SE |