OPALDAM
FDA 510(k) clearance K971284 · decided 1997-06-03
Clearance details
- K-number
- K971284
- Device name
- OPALDAM
- Applicant
- Ultradent Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-04-07
- Decision date
- 1997-06-03
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- EIG
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- South Jordan, UT, 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 |
|---|---|---|
| FIBRELIGHT ILLUMINATING ORAL RETRACTORS (K854711) | Downs Surgical , Ltd. | 1986-02-25 |
| ZOLLER BURNED LIP CONFORMER (K832366) | Universal Prosthetics, Inc. | 1983-09-26 |
| BEACH GINGIVAL RETRACTION INSTR. TYPE B (K821784) | Pacific Dental Corp. | 1982-07-06 |
| GINGITRACT (K771973) | Den-Mat Corp. | 1977-11-07 |
| LIP & CHEEK RETRACTOR (K771399) | L.D. Caulk Co. | 1977-08-26 |
| RACESTYPTINE RINGS (K761024) | Septodont, Inc. | 1976-11-19 |
| RACESTYPTINE CORD (K760657) | Septodont, Inc. | 1976-09-27 |
Recalls involving this device
No recalls on record reference this clearance.