KLS Martin IPS Preprosthetic
FDA 510(k) clearance K210228 · decided 2022-07-08
Clearance details
- K-number
- K210228
- Device name
- KLS Martin IPS Preprosthetic
- Applicant
- KLS-Martin L.P.
- Decision
- Substantially Equivalent
- Date received
- 2021-01-28
- Decision date
- 2022-07-08
- Days to decision
- 526 days
- Clearance type
- Traditional
- Product code
- ELE
- Device class
- 2
- Regulation number
- 872.3645
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Jacksonville, 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 |
|---|---|---|
| SURGICAL VITEX (K862926) | Jeneric Ind. | 1986-08-29 |
| K-APATITE 20-40 MESH K-APATITE 40-60 (K843557) | Katecho, Inc. | 1984-11-30 |
| HOLLOW BASKET TITANIUM DENTAL IMPLANT (K801208) | Colmed, Ltd. | 1980-05-28 |
Recalls involving this device
No recalls on record reference this clearance.