Prosthetic devices · 21 CFR 872 Subpart D
Blade-Form Endosseous Dental Implant
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.
- Companies listing it
- 22 makers
- Brands and models
- 1
- 510(k) clearances
- 51 in five years
- FDA name
- Blade-Form Endosseous Dental Implant
510(k) clearances per year, 1976–2026
Companies that list NRQ
2 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| REX Implants, Inc | United States | Maker | PiezoImplant System | 1 | 2022 |
| Implant Logistics / AMS Micromedical | United States | Maker | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 12 Oct 2022 | K211872 | PiezoImplant System | REX Implants, Inc |
| 25 Jan 1999 | K981954 | VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS | Healthline Implants, Inc. |
| 4 Nov 1982 | K822969 | GENERATION 5 LINKOW BLADE IMPLANTS | Leonard P. Linkow, D.D.L. |
| 9 Oct 1979 | K791366 | ORATRONICS ENDOSSEOUS FRAME ASSEMBLY | Oratronics, Inc. |
| 28 Sep 1979 | K791204 | MITER ENDOSTEAL BLADE IMPLANT | Depuy, Inc. |
Official records: FDA product classification for NRQ · 21 CFR 872.3640.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026