FDA product code NRQ: Blade-Form Endosseous Dental Implant
NRQ is the FDA product code for blade-form endosseous dental implant. It is a Class II device, regulated under 21 CFR 872.3640 and reviewed by the Dental panel. FDA has cleared 5 510(k) submissions under NRQ, 1 in the last five years, from 5 different applicants. The average 510(k) review took 182 days (median 92).
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.
Classification
| Field | Value |
|---|---|
| Device name | Blade-Form Endosseous Dental Implant |
| Device class | Class II |
| Regulation | 21 CFR 872.3640 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NRQ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 482 |
Compare with all 510(k) review times · Search every NRQ clearance
Top NRQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rex Implants, Inc. | 1 | 2022-10-12 |
| Healthline Implants, Inc. | 1 | 1999-01-25 |
| Leonard P. Linkow, D.D.L. | 1 | 1982-11-04 |
| Oratronics, Inc. | 1 | 1979-10-09 |
| Depuy, Inc. | 1 | 1979-09-28 |
Most recent NRQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K211872 | Rex Implants, Inc. | PiezoImplant System | 2022-10-12 | 482 |
| K981954 | Healthline Implants, Inc. | VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS | 1999-01-25 | 235 |
| K822969 | Leonard P. Linkow, D.D.L. | GENERATION 5 LINKOW BLADE IMPLANTS | 1982-11-04 | 27 |
| K791366 | Oratronics, Inc. | ORATRONICS ENDOSSEOUS FRAME ASSEMBLY | 1979-10-09 | 76 |
| K791204 | Depuy, Inc. | MITER ENDOSTEAL BLADE IMPLANT | 1979-09-28 | 92 |
Recalls for NRQ devices
openFDA lists no recalls for product code NRQ.
Frequently asked questions
What is FDA product code NRQ?
NRQ is the FDA product code for blade-form endosseous dental implant. It is a Class II device, regulated under 21 CFR 872.3640 and reviewed by the Dental panel.
What device class is NRQ?
Class II, regulation 21 CFR 872.3640. Typical premarket route: 510(k).
How long does a 510(k) take for product code NRQ?
Across 5 cleared submissions the average was 182 days from receipt to decision (median 92).
Which companies have the most NRQ clearances?
Rex Implants, Inc. (1); Healthline Implants, Inc. (1); Leonard P. Linkow, D.D.L. (1); Oratronics, Inc. (1); Depuy, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NRQ
- Run a recall and safety report across every NRQ manufacturer
- Watch product code NRQ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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