PERF-LOCK IMPRESSION TRAY
FDA 510(k) clearance K801548 · decided 1980-07-21
Clearance details
- K-number
- K801548
- Device name
- PERF-LOCK IMPRESSION TRAY
- Applicant
- Dentsply Intl.
- Decision
- Substantially Equivalent
- Date received
- 1980-07-07
- Decision date
- 1980-07-21
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- EHY
- Device class
- 1
- Regulation number
- 872.6880
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
Recalls involving this device
No recalls on record reference this clearance.