VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS
FDA 510(k) clearance K981954 · decided 1999-01-25
Clearance details
- K-number
- K981954
- Device name
- VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS
- Applicant
- Healthline Implants, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-04
- Decision date
- 1999-01-25
- Days to decision
- 235 days
- Clearance type
- Traditional
- Product code
- NRQ
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Marion, OH, 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 |
|---|---|---|
| PiezoImplant System (K211872) | Rex Implants, Inc. | 2022-10-12 |
| GENERATION 5 LINKOW BLADE IMPLANTS (K822969) | Leonard P. Linkow, D.D.L. | 1982-11-04 |
| ORATRONICS ENDOSSEOUS FRAME ASSEMBLY (K791366) | Oratronics, Inc. | 1979-10-09 |
| MITER ENDOSTEAL BLADE IMPLANT (K791204) | Depuy, Inc. | 1979-09-28 |
Recalls involving this device
No recalls on record reference this clearance.