STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
FDA 510(k) clearance K863500 · decided 1986-09-22
Clearance details
- K-number
- K863500
- Device name
- STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CAR
- Applicant
- Pacific Union Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-09
- Decision date
- 1986-09-22
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- EIS
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Silver Spring, MD, 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 |
|---|---|---|
| ATD AUTOMATIC BRIDGE REMOVER (K992649) | J. Morita USA, Inc. | 1999-10-29 |
| EASY PNEUMATIC CROWN AND BRIDGE REMOVER (K951299) | Dentco, Inc. | 1995-08-29 |
| HAZELTON TEMPORARY CROWN AND BRIDGE REMOVER (K854795) | Fran Hazelton Co. | 1986-03-04 |
| H-TYPE BRIDGE REMOVER (K842026) | Higa Manufacturing , Ltd. | 1984-07-11 |
| SATIN CAST ECONOCAST (K833287) | Genesis Industries, Inc. | 1984-01-03 |
| C & B 40 PENTRO C & B40 (K833290) | Genesis Industries, Inc. | 1984-01-03 |
| C & B 45 (K833278) | Genesis Industries, Inc. | 1983-12-29 |
| GOLD-PALLADIUM-SILVER BASED CAST/ALLOY (K833736) | Jeneric Ind. | 1983-12-29 |
| C & B 61 PENTRON C & B61 (K833289) | Genesis Industries, Inc. | 1983-12-29 |
| SUPRA AP CHOICE 83 (K833280) | Genesis Industries, Inc. | 1983-12-26 |
| RX IV PENTRON IV (K833285) | Genesis Industries, Inc. | 1983-12-22 |
| C & B57 PENTRON C & B57 (K833288) | Genesis Industries, Inc. | 1983-12-20 |
Recalls involving this device
No recalls on record reference this clearance.