510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251926Substantially Equivalent

enCore Impression Material

Encore Guards, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251926 is the FDA 510(k) clearance record for enCore Impression Material, a class II device, cleared for Encore Guards on under FDA product code SHI (Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter). FDA's definition for product code SHI reads: "An over-the-counter device that is intended to reproduce the structure of a patient's teeth and gums for the fabrication of patient-matched mouthguards/nightguards". FDA records list 2 510(k) clearances for Encore Guards, from to . As of , FDA records show no recalls naming K251926.

Clearance record

Decision date
Received
(267 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
Encore Guards 1520 Brookhollow Dr., Santa Ana 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