Material, Impression Tray, Resin
FDA product code EBH · Class I (low risk) · 21 CFR 872.3670 · Dental
30510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
- Dentsply Intl. 5
- Espe GmbH (Us) 3
- Heraeus Kulzer, Inc. 2
- Kulzer, Inc. 2
- Dentron, Inc. 2
- The S. S. White Co. 1
- Bio-Systems Research 1
- E&D Dental Products, Inc. 1
- Productivity Training Corp. 1
- Advantage Dental Products, Inc. 1
- E&D Dental Manufacturing Co. 1
- Ivoclar USA, Inc. 1
- Psp Dental Co., Ltd. 1
- Cutter Laboratories, Inc. 1
- Medi-Dent American, Inc. 1
- Solar Dental Co., Inc. 1
- J. Aderer, Inc. 1
- 3M Company 1
- Oxy Dental Products, Inc. 1
- Sted, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933745 | Permagen Universal Bonding ResinEBH · Traditional | Bio-Systems Research | 01/26/1994SE |
| K930487 | Palatray LC MintEBH · Traditional | Heraeus Kulzer, Inc. | 06/18/1993SE |
| K923979 | LC Tray MaterialEBH · Traditional | Dentsply Intl. | 11/17/1992SE |
| K923549 | Paladisc LCEBH · Traditional | Heraeus Kulzer, Inc. | 09/29/1992SE |
| K912820 | Polyester Resin Hand Molded TrayEBH · Traditional | E&D Dental Products, Inc. | 08/21/1991SE |
| K905058 | Palavit LEBH · Traditional | Kulzer, Inc. | 06/06/1991SE |
| K902350 | Palatray LC Resin Impression Tray MaterialEBH · Traditional | Kulzer, Inc. | 07/26/1990SE |
| K901782 | Convertray Custom Impression Tray Material SystemEBH · Traditional | Productivity Training Corp. | 06/29/1990SE |
| K890712 | Advantage Dental Cust Dent Impress/Baseplate TraysEBH · Traditional | Advantage Dental Products, Inc. | 04/25/1989SE |
| K881838 | Modified Permagum AdhesiveEBH · Traditional | Espe GmbH (Us) | 07/27/1988SE |
| K875257 | Impregum F AdhesiveEBH · Traditional | Espe GmbH (Us) | 03/09/1988SE |
| K875228 | Permadyne AdhesiveEBH · Traditional | Espe GmbH (Us) | 03/09/1988SE |
| K873739 | Acrylic Impression Tray MaterialsEBH · Traditional | E&D Dental Manufacturing Co. | 03/07/1988SE |
| K872210 | Impression TrayEBH · Traditional | Dentsply Intl. | 06/22/1987SE |
| K863421 | Sr-Ivolen Tray MaterialEBH · Traditional | Ivoclar USA, Inc. | 11/03/1986SE |
| K854042 | Resin Tray Impression MaterialEBH · Traditional | Dentsply Intl. | 11/07/1985SE |
| K853093 | PSP Temp - TrayEBH · Traditional | Psp Dental Co., Ltd. | 09/06/1985SE |
| K852182 | Easy Tray & Easy Base Custom Impression Tray MaterEBH · Traditional | The S. S. White Co. | 07/02/1985SE |
| K844471 | Visible Light-Cure Composite -PolishableEBH · Traditional | Dentsply Intl. | 02/08/1985SE |
| K850014 | Hit Kit (Hydrodynamic Impression TechniqueEBH · Traditional | Medi-Dent American, Inc. | 01/23/1985SE |
| K831293 | Solarcryl Custom Tray MaterialEBH · Traditional | Solar Dental Co., Inc. | 07/26/1983SE |
| K820998 | Dentron-Direct-TrayEBH · Traditional | Dentron, Inc. | 06/10/1982SE |
| K820997 | Dentron-Exact - TrayEBH · Traditional | Dentron, Inc. | 06/10/1982SE |
| K813550 | Hybrid Dental ProductEBH · Traditional | Dentsply Intl. | 02/24/1982SE |
| K810686 | Sr-IvolenEBH · Traditional | J. Aderer, Inc. | 04/14/1981SE |
| K802751 | P-10 Posterior Filling MaterialEBH · Traditional | 3M Company | 11/12/1980SE |
| K801780 | Oxy Custom Tray ResinEBH · Traditional | Oxy Dental Products, Inc. | 08/07/1980SE |
| K790897 | Quad IV Custom Impression TrayEBH · Traditional | Sted, Inc. | 06/15/1979SE |
| K782153 | Impression Tray, MDDS CustomEBH · Traditional | Chayet and Sonnenrich, P.C. | 02/26/1979SE |
| K760754 | Cutter Tray-Acrylic for Imp TraysEBH · Traditional | Cutter Laboratories, Inc. | 10/15/1976SE |