SURGICAL VITEX
FDA 510(k) clearance K862926 · decided 1986-08-29
Clearance details
- K-number
- K862926
- Device name
- SURGICAL VITEX
- Applicant
- Jeneric Ind.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-01
- Decision date
- 1986-08-29
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- ELE
- Device class
- 2
- Regulation number
- 872.3645
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Wallingford, CT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Jeneric Ind.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| 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.