BRINKER TISSUE RETRACTORS
FDA 510(k) clearance K780744 · decided 1978-05-12
Clearance details
- K-number
- K780744
- Device name
- BRINKER TISSUE RETRACTORS
- Applicant
- Hygienic Dental Mfg., Co., The
- Decision
- Substantially Equivalent
- Date received
- 1978-04-13
- Decision date
- 1978-05-12
- Days to decision
- 29 days
- Clearance type
- Traditional
- Product code
- EEF
- 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 |
|---|---|---|
| FIXAFLOSS (K071615) | Sybron Dental Specialties, Inc. | 2007-09-21 |
| DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP (K915207) | Bay Technical Products, Inc. | 1992-02-14 |
Recalls involving this device
No recalls on record reference this clearance.