SPLINT IT
FDA 510(k) clearance K972985 · decided 1997-09-24
Clearance details
- K-number
- K972985
- Device name
- SPLINT IT
- Applicant
- Jeneric/Pentron, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-11
- Decision date
- 1997-09-24
- Days to decision
- 44 days
- Clearance type
- Traditional
- Product code
- ELS
- Device class
- 2
- Regulation number
- 872.3890
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Wallingford, CT, 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 |
|---|---|---|
| MTI-MP TRANSITIONAL IMPLANTS AND MODULAR PROSTHETIC SYSTEM (K961704) | Dentatus USA , Ltd. | 1996-07-26 |
| FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDING (K922673) | Glasspan, Inc. | 1994-02-25 |
| ENDIX RADICULAR BIOCERAMIC PIN (K834363) | C.B.S. Biotechnics, Inc. | 1984-02-27 |
| JACOB WIRZ TRANSFIXATION PIN (K811209) | Colmed, Ltd. | 1981-06-16 |
| ZEST ENDODONTIC STABILIZER (K801525) | Zest Anchors, Inc. | 1980-07-21 |
Recalls involving this device
No recalls on record reference this clearance.