Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SOMATICS MOUTH GUARD (BITE BLOCK)

K-Number: K864181 · 1986-11-03

ApplicantSomatics, Inc.
Decision Date1986-11-03
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SOMATICS MOUTH GUARD (BITE BLOCK) is the device name listed in this FDA 510(k) record. The listed applicant is Somatics, Inc.. It received FDA 510(k) clearance on 1986-11-03 under 510(k) number K864181. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMATICS MOUTH GUARD (BITE BLOCK)?

SOMATICS MOUTH GUARD (BITE BLOCK) is a medical device that received FDA 510(k) clearance on 1986-11-03. The listed applicant is Somatics, Inc.. The 510(k) number is K864181.

When did SOMATICS MOUTH GUARD (BITE BLOCK) receive FDA 510(k) clearance?

SOMATICS MOUTH GUARD (BITE BLOCK) received FDA 510(k) clearance on 1986-11-03, under 510(k) number K864181.

Who is the listed applicant for SOMATICS MOUTH GUARD (BITE BLOCK)?

The FDA 510(k) record lists Somatics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOMATICS MOUTH GUARD (BITE BLOCK)?

The FDA product code for SOMATICS MOUTH GUARD (BITE BLOCK) is JXL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Somatics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K992269VENTIL-A ORAL PROTECTORK945120THYMATRON 2000 ELECTROCONVULSIVE SYSTEMK890711DUAL GRAPH (TM) RECORDER-MONITORK890710DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDSK882809THYMAPADK843923THYMATRON

View all 7 devices →

Related Devices (Code: JXL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221469PATI (Protector Against Tongue Injury)Neurovice, LLCK201309ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta CorporationK172978SurgeoBiteSurgovations, LLCK050188EPIGUARDEpisafe Medical Devices, Ltd.K992269VENTIL-A ORAL PROTECTORSomatics, Inc.K960663UNIVERSAL BITE BLOCKB&B Medical Technologies, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑