Attachment, Precision, All
FDA product code EGG · Class I (low risk) · 21 CFR 872.3165 · Dental
24510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Zest Anchors, Inc. 3
- Howmedica Corp. 2
- Metalor Dental USA Corp. 2
- Interpore Intl. 2
- Steco-System-Technik GmbH & Cokg 1
- Dr. Joseph E. Grasso, D.D.S. 1
- Cogan Corp. 1
- Inodent 1
- Gayso Bridge-Tech, Inc. 1
- Implant Support Systems, Inc. 1
- Health Technology of America, Inc. 1
- Cosmetic Dental Technologies, Inc. 1
- Js & R - R & D Co. 1
- Parker Laboratories, Inc. 1
- Solid State Innovations, Inc. 1
- Magne-Dent 1
- Denta, Inc. 1
- Duradent Corp. 1
- Zl-Microdent-Attachments 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K990979 | Steco-TitanmagneticsEGG · Traditional | Steco-System-Technik GmbH & Cokg | 09/03/1999SE |
| K950259 | Coupling Device for Dental ProsthesisEGG · Traditional | Dr. Joseph E. Grasso, D.D.S. | 12/06/1996SE |
| K925700 | Zest Anchor Advanced GenerationEGG · Traditional | Zest Anchors, Inc. | 04/07/1994SE |
| K915299 | Cogan Corp Kits of Dental Hand InstrumentsEGG · Traditional | Cogan Corp. | 01/31/1992SE |
| K912435 | Dental Connector Precision AttachmentEGG · Traditional | Metalor Dental USA Corp. | 08/28/1991SE |
| K912567 | Conicast, Intracast, OmecastEGG · Traditional | Metalor Dental USA Corp. | 07/02/1991SE |
| K901928 | Interpore Imz(Castable)Tub/Scret Ret Rigid AttachEGG · Traditional | Interpore Intl. | 07/26/1990SE |
| K900785 | Micro 2 SystemEGG · Traditional | Inodent | 04/16/1990SE |
| K896337 | Dental Bridge Anchoring PinsEGG · Traditional | Gayso Bridge-Tech, Inc. | 01/31/1990SE |
| K895986 | Precision Dental AttachmentsEGG · Traditional | Implant Support Systems, Inc. | 10/18/1989SE |
| K891119 | T.R.S.: Tooth Replacement SystemEGG · Traditional | Health Technology of America, Inc. | 04/17/1989SE |
| K882063 | Magne-Dent Magnet/Zest Retrofit KeeperEGG · Traditional | Zest Anchors, Inc. | 06/13/1988SE |
| K871439 | Cosmetic Single Span BridgeEGG · Traditional | Cosmetic Dental Technologies, Inc. | 06/08/1987SE |
| K870331 | Imz Intramobile Cylinder Implant System ComponentsEGG · Traditional | Interpore Intl. | 03/02/1987SE |
| K863243 | Shiner Stress Directing AttachmentEGG · Traditional | Js & R - R & D Co. | 10/30/1986SE |
| K861561 | Zest Mark II (Standard & Mini)EGG · Traditional | Zest Anchors, Inc. | 05/21/1986SE |
| K855167 | Dyna SystemEGG · Traditional | Parker Laboratories, Inc. | 03/04/1986SE |
| K854633 | Jackson Rare Earth Magnetic AttachmentEGG · Traditional | Solid State Innovations, Inc. | 01/30/1986SE |
| K840600 | Magne-DentEGG · Traditional | Magne-Dent | 04/30/1984SE |
| K830439 | Denta A-33EGG · Traditional | Denta, Inc. | 05/09/1983SE |
| K823280 | DistaflexEGG · Traditional | Duradent Corp. | 11/22/1982SE |
| K812360 | Precious-Metal/Plastic Attach., AuxillEGG · Traditional | Zl-Microdent-Attachments | 09/21/1981SE |
| K791788 | Micro-Ring System Precision Attach.EGG · Traditional | Howmedica Corp. | 10/22/1979SE |
| K780711 | Micro-RingEGG · Traditional | Howmedica Corp. | 05/26/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1037-2008 | Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04…Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection… | Straumann Usa, Llc | 01/10/2008Terminated |