ORATRONICS ENDOSSEOUS FRAME ASSEMBLY
FDA 510(k) clearance K791366 · decided 1979-10-09
Clearance details
- K-number
- K791366
- Device name
- ORATRONICS ENDOSSEOUS FRAME ASSEMBLY
- Applicant
- Oratronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-07-25
- Decision date
- 1979-10-09
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- NRQ
- Device class
- 2
- Regulation number
- 872.3640
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Oratronics
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 |
|---|---|---|
| PiezoImplant System (K211872) | Rex Implants, Inc. | 2022-10-12 |
| VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS (K981954) | Healthline Implants, Inc. | 1999-01-25 |
| GENERATION 5 LINKOW BLADE IMPLANTS (K822969) | Leonard P. Linkow, D.D.L. | 1982-11-04 |
| MITER ENDOSTEAL BLADE IMPLANT (K791204) | Depuy, Inc. | 1979-09-28 |
Recalls involving this device
No recalls on record reference this clearance.