HYGIENIC 5 & 6 RUBBER DAM FRAME
FDA 510(k) clearance K770117 · decided 1977-01-28
Clearance details
- K-number
- K770117
- Device name
- HYGIENIC 5 & 6 RUBBER DAM FRAME
- Applicant
- Hygienic Dental Mfg., Co., The
- Decision
- Substantially Equivalent
- Date received
- 1977-01-21
- Decision date
- 1977-01-28
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- EJE
- Device class
- 1
- Regulation number
- 872.6300
- 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 |
|---|---|---|
| RUBBER DAM HOLDER (K781520) | Young Dental Manufacturing Co. 1, LLC | 1978-10-10 |
| HYGIENIC RUBBER DAM FRAME (K780746) | Hygienic Dental Mfg., Co., The | 1978-05-12 |
Recalls involving this device
No recalls on record reference this clearance.