510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NPKClass II

Barrier, Synthetic, Intraoral

21 CFR 872.3930 / Dental
FDA source (opens on fda.gov)

NPK is the FDA product code for Barrier, Synthetic, Intraoral, a class II device type, regulated under 21 CFR 872.3930. FDA's definition for this code reads: "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". As of , FDA records hold 31 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
NPK
Device name
Barrier, Synthetic, Intraoral
FDA 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.
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
31
Ingested recalls
1

Clearances, product code NPK

By decision year
31 clearances under product code NPK with a decision year between 1986 and 2023, 1997 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code NPK by decision year
YearClearances
19861
19932
19942
19963
19974
19982
19991
20041
20051
20091
20102
20111
20131
20152
20161
20171
20211
20221
20233

Applicants with the most clearances

Product code NPK
Applicants holding the most 510(k) clearances under product code NPK
ApplicantClearances
W. L. Gore & Associates, Inc.5
American Custom Medical, Inc.3
Atrix Laboratories, Inc.2
Imtec Corp.2
Osteogenics Biomedical, Inc.2
Porex Surgical, Inc.2
B&Medi Co., Ltd.1
Cowellmedi Co., Ltd.1
Criteria Industria E Comercio de Produtos Medicinais1
Ethicon, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order