510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971517Substantially Equivalent

Silicone Putty Ear Plugs

Bentec Medical, Inc., Sacramento CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971517 is the FDA 510(k) clearance record for SILICONE PUTTY EAR PLUGS, cleared for Bentec Medical, Inc. on under FDA product code EWD (Protector, Hearing (Insert)). FDA records list 3 510(k) clearances for Bentec Medical, Inc., from to . As of , FDA records show no recalls naming K971517.

Clearance record

Decision date
Received
(38 days to decision)
Product code
EWD Protector, Hearing (Insert)
Device class
Unclassified
Review panel
Unknown
Applicant
Bentec Medical, Inc. 4234 N. Fwy. Blvd., Sacramento CA
510(k) summary
Statement
Third party review
No

Clearances, product code EWD

Trailing 12 months

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

FDA records show no clearances under product code EWD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EWD, 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