510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K261888Substantially Equivalent

ClearClub Impression Material

ClearClub, Inglewood CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(103 days to decision)
Product code
SHI Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
ClearClub 8915 S La Cienega Blvd., Inglewood CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SHI

Trailing 12 months
3 clearances under product code SHI in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260