NRQ
5 FDA 510(k) clearances · Product code
92 daysmedian time to decision
482 days90th percentile
5clearances measured
FDA profile
- Official device name
- Blade-Form Endosseous Dental Implant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.3640
- Medical specialty
- Dental
- Flags
- Implant
- FDA definition
- Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| 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 |
| ORATRONICS ENDOSSEOUS FRAME ASSEMBLY (K791366) | Oratronics, Inc. | 1979-10-09 |
| MITER ENDOSTEAL BLADE IMPLANT (K791204) | Depuy, Inc. | 1979-09-28 |
Track NRQ automatically
Every clearance here is in the API, with alerts when new ones post.