← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
PEM — Dental Barriers And Sleeves
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
DEVICE CLASS
Class II
REGULATION
21 CFR 878.4370
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES
Recent clearances
K250735Fomed Industries, Inc. · 510k2025-06-10
K250606Yueying Medical Instruments (Langfang) Co., Ltd. · 510k2025-05-29
K242435Wellmed Dental Medical Supply Co., Ltd. · 510k2024-10-18
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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