EGG · Attachment, Precision, All
Dental · 21 CFR 872.3165 · Class 1
Overview
| Product Code | EGG |
|---|---|
| Device Name | Attachment, Precision, All |
| Regulation | 21 CFR 872.3165 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A precision attachment or preformed bar is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 24)
Showing 20 most recent of 24 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K990979 | STECO-TITANMAGNETICS | Steco-System-Technik GmbH & Cokg | Sep 3, 1999 | SESE |
| K950259 | COUPLING DEVICE FOR DENTAL PROSTHESIS | Dr. Joseph E. Grasso, D.D.S. | Dec 6, 1996 | SESE |
| K925700 | ZEST ANCHOR ADVANCED GENERATION | Zest Anchors, Inc. | Apr 7, 1994 | SESE |
| K915299 | COGAN CORP KITS OF DENTAL HAND INSTRUMENTS | Cogan Corp. | Jan 31, 1992 | SESE |
| K912435 | DENTAL CONNECTOR PRECISION ATTACHMENT | Metalor Dental USA Corp. | Aug 28, 1991 | SESE |
| K912567 | CONICAST, INTRACAST, OMECAST | Metalor Dental USA Corp. | Jul 2, 1991 | SESE |
| K901928 | INTERPORE IMZ(CASTABLE)TUB/SCRET RET RIGID ATTACH | Interpore Intl. | Jul 26, 1990 | SESE |
| K900785 | MICRO 2 SYSTEM | Inodent | Apr 16, 1990 | SESE |
| K896337 | DENTAL BRIDGE ANCHORING PINS | Gayso Bridge-Tech, Inc. | Jan 31, 1990 | SESE |
| K895986 | PRECISION DENTAL ATTACHMENTS | Implant Support Systems, Inc. | Oct 18, 1989 | SESE |
| K891119 | T.R.S.: TOOTH REPLACEMENT SYSTEM | Health Technology of America, Inc. | Apr 17, 1989 | SESE |
| K882063 | MAGNE-DENT MAGNET/ZEST RETROFIT KEEPER | Zest Anchors, Inc. | Jun 13, 1988 | SESE |
| K871439 | COSMETIC SINGLE SPAN BRIDGE | Cosmetic Dental Technologies, Inc. | Jun 8, 1987 | SESE |
| K870331 | IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS | Interpore Intl. | Mar 2, 1987 | SESE |
| K863243 | SHINER STRESS DIRECTING ATTACHMENT | Js & R - R & D Co. | Oct 30, 1986 | SESE |
| K861561 | ZEST MARK II (STANDARD & MINI) | Zest Anchors, Inc. | May 21, 1986 | SESE |
| K855167 | DYNA SYSTEM | Parker Laboratories, Inc. | Mar 4, 1986 | SESE |
| K854633 | JACKSON RARE EARTH MAGNETIC ATTACHMENT | Solid State Innovations, Inc. | Jan 30, 1986 | SESE |
| K840600 | MAGNE-DENT | Magne-Dent | Apr 30, 1984 | SESE |
| K830439 | DENTA A-33 | Denta, Inc. | May 9, 1983 | SESE |
Top Applicants
- Zest Anchors, Inc. — 3 clearances
- Metalor Dental USA Corp. — 2 clearances
- Interpore Intl. — 2 clearances
- Howmedica Corp. — 2 clearances
- Zl-Microdent-Attachments — 1 clearance
