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

Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter

21 CFR 872.3660 / Dental
FDA source (opens on fda.gov)

SHI is the FDA product code for Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter, a class II device type, regulated under 21 CFR 872.3660. FDA's definition for this code 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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
SHI
Device name
Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
FDA definition
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.
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code SHI

By decision year
3 clearances under product code SHI with a decision year between 2026 and 2026, 2026 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code SHI by decision year
YearClearances
20263

Applicants with the most clearances

Product code SHI
Applicants holding the most 510(k) clearances under product code SHI
ApplicantClearances
ClearClub1
Encore Guards1
Grindguard Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code