FIXAFLOSS
FDA 510(k) clearance K071615 · decided 2007-09-21
Clearance details
- K-number
- K071615
- Device name
- FIXAFLOSS
- Applicant
- Sybron Dental Specialties, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-06-13
- Decision date
- 2007-09-21
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- EEF
- Device class
- 1
- Regulation number
- 872.6300
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Orange, CA, 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 |
|---|---|---|
| DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP (K915207) | Bay Technical Products, Inc. | 1992-02-14 |
| BRINKER TISSUE RETRACTORS (K780744) | Hygienic Dental Mfg., Co., The | 1978-05-12 |
Recalls involving this device
No recalls on record reference this clearance.