FDA product code NPK: Barrier, Synthetic, Intraoral
NPK is the FDA product code for barrier, synthetic, intraoral. It is a Class II device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel. FDA has cleared 31 510(k) submissions under NPK, 4 in the last five years, from 21 different applicants. The average 510(k) review took 240 days (median 160). FDA has posted 1 recall for NPK devices.
Definition
A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.
Classification
| Field | Value |
|---|---|
| Device name | Barrier, Synthetic, Intraoral |
| Device class | Class II |
| Regulation | 21 CFR 872.3930 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NPK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 127 |
| 2021 | 1 | 267 |
| 2022 | 1 | 520 |
| 2023 | 3 | 479 |
Compare with all 510(k) review times · Search every NPK clearance
Top NPK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| W. L. Gore & Associates, Inc. | 5 | 2005-06-15 |
| American Custom Medical, Inc. | 3 | 1997-04-30 |
| Osteogenics Biomedical, Inc. | 2 | 2021-01-23 |
| Porex Surgical, Inc. | 2 | 2011-01-07 |
| Atrix Laboratories, Inc. | 2 | 1998-09-08 |
16 more applicants have NPK clearances. See the full list in Caduvo.
Most recent NPK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221851 | Criteria Industria E Comercio DE Produtos Medicinais | Lumina-PTFE Titanium | 2023-12-08 | 529 |
| K222549 | Purgo Biologics, Inc. | OpenTex | 2023-05-11 | 261 |
| K211554 | Cowellmedi Co., Ltd. | InnoGenic Non-resorbable Membrane | 2023-02-24 | 646 |
| K210797 | B&Medi Co., Ltd. | Bio-MEM Ti Reinforced Membrane | 2022-08-18 | 520 |
| K201187 | Osteogenics Biomedical, Inc. | Cytoplast Titanium-Reinforced PTFE Membranes | 2021-01-23 | 267 |
Recalls for NPK devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-03-01.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code NPK?
NPK is the FDA product code for barrier, synthetic, intraoral. It is a Class II device, regulated under 21 CFR 872.3930 and reviewed by the Dental panel.
What device class is NPK?
Class II, regulation 21 CFR 872.3930. Typical premarket route: 510(k).
How long does a 510(k) take for product code NPK?
Across 31 cleared submissions the average was 240 days from receipt to decision (median 160).
Which companies have the most NPK clearances?
W. L. Gore & Associates, Inc. (5); American Custom Medical, Inc. (3); Osteogenics Biomedical, Inc. (2); Porex Surgical, Inc. (2); Atrix Laboratories, Inc. (2).
Have NPK devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-03-01.
Next steps
- Run an FDA pathway report with predicate devices for product code NPK
- Run a recall and safety report across every NPK manufacturer
- Watch product code NPK 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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