K-APATITE 20-40 MESH K-APATITE 40-60
FDA 510(k) clearance K843557 · decided 1984-11-30
Clearance details
- K-number
- K843557
- Device name
- K-APATITE 20-40 MESH K-APATITE 40-60
- Applicant
- Katecho, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-10
- Decision date
- 1984-11-30
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- ELE
- Device class
- 2
- Regulation number
- 872.3645
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Des Moines, IA, 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 |
|---|---|---|
| KLS Martin IPS Preprosthetic (K210228) | KLS-Martin L.P. | 2022-07-08 |
| SURGICAL VITEX (K862926) | Jeneric Ind. | 1986-08-29 |
| HOLLOW BASKET TITANIUM DENTAL IMPLANT (K801208) | Colmed, Ltd. | 1980-05-28 |
Recalls involving this device
No recalls on record reference this clearance.