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

Dental Barriers And Sleeves

21 CFR 878.4370 / General, Plastic Surgery
FDA source (opens on fda.gov)

PEM is the FDA product code for Dental Barriers And Sleeves, a class II device type, regulated under 21 CFR 878.4370. FDA's definition for this code reads: "Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients". As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PEM
Device name
Dental Barriers And Sleeves
FDA definition
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
17
Ingested recalls
0

Clearances, product code PEM

By decision year
17 clearances under product code PEM with a decision year between 2014 and 2026, 2019 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code PEM by decision year
YearClearances
20141
20162
20171
20194
20201
20211
20221
20242
20252
20262

Applicants with the most clearances

Product code PEM
Applicants holding the most 510(k) clearances under product code PEM
ApplicantClearances
ANI Co., Ltd.1
Air Techniques, Inc.1
BH Medical Products Co., Ltd1
Dentsply International, Inc.1
Dürr Dental SE1
Fomed Industries Inc1
Ivoclar Vivadent, Inc.1
Minitube AB1
Pac-Dent International, Inc.1
Plasdent Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 47 companies shown, in name order