Tray, Impression, Preformed
The Preformed Impression Tray is a prefabricated, standardized tray made of metal or plastic used to hold impression material in the correct position while it sets, allowing dental practitioners to capture an accurate three-dimensional record of oral structures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EHY, regulated under 21 CFR 872.6880 in the Dental (DE) specialty. This device is exempt from GMP requirements.
Basic Information
- Product Code
- EHY
- Device Class
- FDA class 1
- Regulation Number
- 872.6880
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K942668 | O-TRAY IMPRESSION TRAYS | Jul 22, 1994 | Substantially Equivalent | Dentauraum, Inc. |
| K896470 | EOS IMPRESSION TRAYS | Feb 09, 1990 | Substantially Equivalent | Ivoclar North America, Inc. |
| K884316 | OCCLUSAL HARMONY IMPRESSION TRAY | Dec 22, 1988 | Substantially Equivalent | Advantage Dental Co. |
| K863836 | POST TRAY | Oct 14, 1986 | Substantially Equivalent | Market Masters, Inc. |
| K850776 | PREFORMED DENTAL IMPRESSION TRAYS | Mar 18, 1985 | Substantially Equivalent | L.A.K. Ent., Inc. |
| K842274 | F-G-P TRAY | Jul 31, 1984 | Substantially Equivalent | Di-Equi Dental Products |
| K842273 | CROWN INDEX TRAY | Jul 31, 1984 | Substantially Equivalent | Di-Equi Dental Products |
| K841491 | CONVENTIONAL PLASTIC DENTAL TRAYS | Jul 13, 1984 | Substantially Equivalent | Buffalo Dental Mfg. Co., Inc. |
| K841323 | FUZZY TRAY | Jun 27, 1984 | Substantially Equivalent | Buffalo Dental Mfg. Co., Inc. |
| K833485 | IMPRESSION TUBE ADJUSTABLE | Dec 26, 1983 | Substantially Equivalent | Zefr, Inc. |
| K810525 | SR-IVOTRAY UNIVERSAL | Mar 17, 1981 | Substantially Equivalent | J. Aderer, Inc. |
| K810524 | SR-IVOTRAY SPECIAL | Mar 17, 1981 | Substantially Equivalent | J. Aderer, Inc. |
| K801548 | PERF-LOCK IMPRESSION TRAY | Jul 21, 1980 | Substantially Equivalent | Dentsply Intl. |
| K800900 | PREMIER TRIPLE TRAY | Apr 29, 1980 | Substantially Equivalent | Premier Dental Products Co. |
| K780678 | IMPRESSION TRAY | Apr 28, 1978 | Substantially Equivalent | Rocky Mountain Orthodontics, Inc. |
| K780211 | 4-IN-1 DISP. CROWN & BRIDGE TRAY | Feb 16, 1978 | Substantially Equivalent | Kerr Corporation (Danbury) |
FEI Numbers
This FDA classification entry is associated with 317 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 317 registration numbers. Click on an entry to view related FDA registrations.