Class Class II

Dental Barrier and Sleeves (K250735)

K250735 2025-06-10 Traditional
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Description

Dental Barrier and Sleeves by Fomed Industries, Inc., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK250735
Clearance Date2025-06-10
Clearance TypeTraditional
Product CodePEM
Regulation Number878.4370

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