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510(k) K992269

VENTIL-A ORAL PROTECTOR by Somatics, Inc. — Product Code JXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1999
Date Received
July 6, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Block, Bite
Device Class
Class II
Regulation Number
882.5070
Review Panel
NE
Submission Type

Other clearances by Somatics, Inc.

  • K945120 — THYMATRON 2000 ELECTROCONVULSIVE SYSTEM (October 26, 1995)
  • K890711 — DUAL GRAPH (TM) RECORDER-MONITOR (June 2, 1989)
  • K890710 — DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS (March 14, 1989)
  • K882809 — THYMAPAD (September 27, 1988)
  • K864181 — SOMATICS MOUTH GUARD (BITE BLOCK) (November 3, 1986)
  • K843923 — THYMATRON (December 3, 1984)

Other clearances for product code JXL

  • K221469 — PATI (Protector Against Tongue Injury) (February 22, 2023)
  • K201309 — ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium (June 4, 2021)
  • K172978 — SurgeoBite (December 22, 2017)
  • K150518 — Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and To (June 29, 2015)
  • K050188 — EPIGUARD (April 27, 2005)
  • K960663 — UNIVERSAL BITE BLOCK (May 17, 1996)
  • K954352 — BITE BLOCK (January 25, 1996)
  • K941856 — PREMIER PROMAX BITE GUARD (April 5, 1995)
  • K924333 — THE DAVIS DISPOSABLE PROTECTIVE SPLINT (April 23, 1993)
  • K924304 — BITE BLOCK (April 6, 1993)