510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935713Substantially Equivalent

Wiley/esposito Dental Guard

Fvtnks, Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935713 is the FDA 510(k) clearance record for WILEY/ESPOSITO DENTAL GUARD, a class I device, cleared for Fvtnks on under FDA product code BRW (Protector, Dental). FDA records list 4 510(k) clearances for Fvtnks, from to . As of , FDA records show no recalls naming K935713.

Clearance record

Decision date
Received
(36 days to decision)
Product code
BRW Protector, Dental
Regulation
21 CFR 868.5820
Device class
Class I
Review panel
Anesthesiology
Applicant
Fvtnks 10415 Briggs Ct., Indianapolis IN
510(k) summary
Statement
Third party review
No

Clearances, product code BRW

Trailing 12 months

FDA records hold no clearances under product code BRW in the trailing twelve months.

FDA records show no clearances under product code BRW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BRW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260