EHY · Tray, Impression, Preformed
Dental · 21 CFR 872.6880 · Class 1
Overview
| Product Code | EHY |
|---|---|
| Device Name | Tray, Impression, Preformed |
| Regulation | 21 CFR 872.6880 |
| Device Class | Class 1 |
| Review Panel | Dental |
| GMP Exempt | Yes |
Identification
A preformed impression tray is a metal or plastic device intended to hold impression material, such as alginate, to make an impression of a patient's teeth or alveolar process (bony tooth sockets) to reproduce the structure of a patient's teeth and gums.
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. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K942668 | O-TRAY IMPRESSION TRAYS | Dentauraum, Inc. | Jul 22, 1994 | SESE |
| K896470 | EOS IMPRESSION TRAYS | Ivoclar North America, Inc. | Feb 9, 1990 | SESE |
| K884316 | OCCLUSAL HARMONY IMPRESSION TRAY | Advantage Dental Co. | Dec 22, 1988 | SESE |
| K863836 | POST TRAY | Market Masters, Inc. | Oct 14, 1986 | SESE |
| K850776 | PREFORMED DENTAL IMPRESSION TRAYS | L.A.K. Ent., Inc. | Mar 18, 1985 | SESE |
| K842274 | F-G-P TRAY | Di-Equi Dental Products | Jul 31, 1984 | SESE |
| K842273 | CROWN INDEX TRAY | Di-Equi Dental Products | Jul 31, 1984 | SESE |
| K841491 | CONVENTIONAL PLASTIC DENTAL TRAYS | Buffalo Dental Mfg. Co., Inc. | Jul 13, 1984 | SESE |
| K841323 | FUZZY TRAY | Buffalo Dental Mfg. Co., Inc. | Jun 27, 1984 | SESE |
| K833485 | IMPRESSION TUBE ADJUSTABLE | Zefr, Inc. | Dec 26, 1983 | SESE |
| K810525 | SR-IVOTRAY UNIVERSAL | J. Aderer, Inc. | Mar 17, 1981 | SESE |
| K810524 | SR-IVOTRAY SPECIAL | J. Aderer, Inc. | Mar 17, 1981 | SESE |
| K801548 | PERF-LOCK IMPRESSION TRAY | Dentsply Intl. | Jul 21, 1980 | SESE |
| K800900 | PREMIER TRIPLE TRAY | Premier Dental Products Co. | Apr 29, 1980 | SESE |
| K780678 | IMPRESSION TRAY | Rocky Mountain Orthodontics, Inc. | Apr 28, 1978 | SESE |
| K780211 | 4-IN-1 DISP. CROWN & BRIDGE TRAY | Kerr Corporation (Danbury) | Feb 16, 1978 | SESE |
Top Applicants
- Buffalo Dental Mfg. Co., Inc. — 2 clearances
- Di-Equi Dental Products — 2 clearances
- J. Aderer, Inc. — 2 clearances
- Advantage Dental Co. — 1 clearance
- Dentauraum, Inc. — 1 clearance
