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
SUBSCRIBE / SIGN IN
K864181Substantially Equivalent

Somatics Mouth Guard (Bite Block)

Somatics, LLC, Lake Bluff IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864181 is the FDA 510(k) clearance record for SOMATICS MOUTH GUARD (BITE BLOCK), a class II device, cleared for Somatics, Inc. on under FDA product code JXL (Block, Bite). FDA records list 7 510(k) clearances for Somatics, Inc., from to . As of , FDA records show no recalls naming K864181.

Clearance record

Decision date
Received
(7 days to decision)
Product code
JXL Block, Bite
Regulation
21 CFR 882.5070
Device class
Class II
Review panel
Neurology
Applicant
Somatics, Inc. 910 Sherwood Dr., Unit 17, Lake Bluff IL
Third party review
No

Clearances, product code JXL

Trailing 12 months

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

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