GLENROE BAND SEATING CONTOURING INSTRUMENT
FDA 510(k) clearance K924993 · decided 1992-11-25
Clearance details
- K-number
- K924993
- Device name
- GLENROE BAND SEATING CONTOURING INSTRUMENT
- Applicant
- Glenroe Technologies
- Decision
- Substantially Equivalent
- Date received
- 1992-10-01
- Decision date
- 1992-11-25
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- ECS
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Bradenton, FL, 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 |
|---|---|---|
| MERSHON BAND PUSHER (K935155) | Dentauraum, Inc. | 1994-02-04 |
Recalls involving this device
No recalls on record reference this clearance.