EHY
16 FDA 510(k) clearances · Product code
46 daysmedian time to decision
88 days90th percentile
16clearances measured
FDA profile
- Official device name
- Tray, Impression, Preformed
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6880
- Medical specialty
- Dental
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| O-TRAY IMPRESSION TRAYS (K942668) | Dentauraum, Inc. | 1994-07-22 |
| EOS IMPRESSION TRAYS (K896470) | Ivoclar North America, Inc. | 1990-02-09 |
| OCCLUSAL HARMONY IMPRESSION TRAY (K884316) | Advantage Dental Co. | 1988-12-22 |
| POST TRAY (K863836) | Market Masters, Inc. | 1986-10-14 |
| PREFORMED DENTAL IMPRESSION TRAYS (K850776) | L.A.K. Ent., Inc. | 1985-03-18 |
| CROWN INDEX TRAY (K842273) | Di-Equi Dental Products | 1984-07-31 |
| F-G-P TRAY (K842274) | Di-Equi Dental Products | 1984-07-31 |
| CONVENTIONAL PLASTIC DENTAL TRAYS (K841491) | Buffalo Dental Mfg. Co., Inc. | 1984-07-13 |
| FUZZY TRAY (K841323) | Buffalo Dental Mfg. Co., Inc. | 1984-06-27 |
| IMPRESSION TUBE ADJUSTABLE (K833485) | Zefr, Inc. | 1983-12-26 |
| SR-IVOTRAY SPECIAL (K810524) | J. Aderer, Inc. | 1981-03-17 |
| SR-IVOTRAY UNIVERSAL (K810525) | J. Aderer, Inc. | 1981-03-17 |
| PERF-LOCK IMPRESSION TRAY (K801548) | Dentsply Intl. | 1980-07-21 |
| PREMIER TRIPLE TRAY (K800900) | Premier Dental Products Co. | 1980-04-29 |
| IMPRESSION TRAY (K780678) | Rocky Mountain Orthodontics, Inc. | 1978-04-28 |
| 4-IN-1 DISP. CROWN & BRIDGE TRAY (K780211) | Kerr Corporation (Danbury) | 1978-02-16 |
Track EHY automatically
Every clearance here is in the API, with alerts when new ones post.