510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K860737Substantially Equivalent

Teen Clean, Retainer Cleaner

Teen Care, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860737 is the FDA 510(k) clearance record for TEEN CLEAN, RETAINER CLEANER, a class I device, cleared for Teen Care, Inc. on under FDA product code EFT (Cleanser, Denture, Over The Counter). FDA records list one 510(k) clearance for Teen Care, Inc. As of , FDA records show no recalls naming K860737.

Clearance record

Decision date
Received
(27 days to decision)
Product code
EFT Cleanser, Denture, Over The Counter
Regulation
21 CFR 872.3520
Device class
Class I
Review panel
Dental
Applicant
Teen Care, Inc. Stuart Lee Friedel, New York NY
Third party review
No

Clearances, product code EFT

Trailing 12 months

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

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