Product code EHY
- Device name
- Tray, Impression, Preformed
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6880
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K942668 | O-TRAY IMPRESSION TRAYS | Dentauraum, Inc. | 1994-07-22 |
| K896470 | EOS IMPRESSION TRAYS | Ivoclar North America, Inc. | 1990-02-09 |
| K884316 | OCCLUSAL HARMONY IMPRESSION TRAY | Advantage Dental Co. | 1988-12-22 |
| K863836 | POST TRAY | Market Masters, Inc. | 1986-10-14 |
| K850776 | PREFORMED DENTAL IMPRESSION TRAYS | L.A.K. Ent., Inc. | 1985-03-18 |
| K842273 | CROWN INDEX TRAY | Di-Equi Dental Products | 1984-07-31 |
| K842274 | F-G-P TRAY | Di-Equi Dental Products | 1984-07-31 |
| K841491 | CONVENTIONAL PLASTIC DENTAL TRAYS | Buffalo Dental Mfg. Co., Inc. | 1984-07-13 |
| K841323 | FUZZY TRAY | Buffalo Dental Mfg. Co., Inc. | 1984-06-27 |
| K833485 | IMPRESSION TUBE ADJUSTABLE | Zefr, Inc. | 1983-12-26 |
| K810524 | SR-IVOTRAY SPECIAL | J. Aderer, Inc. | 1981-03-17 |
| K810525 | SR-IVOTRAY UNIVERSAL | J. Aderer, Inc. | 1981-03-17 |
| K801548 | PERF-LOCK IMPRESSION TRAY | Dentsply Intl. | 1980-07-21 |
| K800900 | PREMIER TRIPLE TRAY | Premier Dental Products Co. | 1980-04-29 |
| K780678 | IMPRESSION TRAY | Rocky Mountain Orthodontics, Inc. | 1978-04-28 |
| K780211 | 4-IN-1 DISP. CROWN & BRIDGE TRAY | Kerr Corporation (Danbury) | 1978-02-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D1254324 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-06-08 |
| D1254314 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-06-08 |
| D1254184 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1254204 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1254194 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1254174 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1254164 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1254154 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1254144 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1254134 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1254124 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1254114 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1254104 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| D1254304 | Premium Plus | Premium Plus (Dongguan) Limited | 2026-05-27 |
| ESAM5201031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5201021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5201011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5201001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5176061 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5176051 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5176041 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5176031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5176021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5176011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5171061 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5171051 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5171041 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5171031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5171021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM5171011 | STOMA® | Storz am Mark GmbH | 2020-08-27 |