NRQ — Blade-Form Endosseous Dental Implant Class II
FDA product code NRQ covers "Blade-Form Endosseous Dental Implant", a Class II medical device regulated under 21 CFR 872.3640. Submissions are reviewed by the Dental panel. Devices under this code are implants. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NRQ
- Device Class
- Class II
- Regulation Number
- 872.3640
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K211872 | rex implants | PiezoImplant System | October 12, 2022 |
| K981954 | healthline implants | VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS | January 25, 1999 |
| K822969 | leonard p. linkow, d.d.l | GENERATION 5 LINKOW BLADE IMPLANTS | November 4, 1982 |
| K791366 | oratronics | ORATRONICS ENDOSSEOUS FRAME ASSEMBLY | October 9, 1979 |
| K791204 | depuy | MITER ENDOSTEAL BLADE IMPLANT | September 28, 1979 |