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510(k) K050188

EPIGUARD by Episafe Medical Devices, Ltd. — Product Code JXL

K050188 is an FDA 510(k) premarket notification submitted by Episafe Medical Devices, Ltd. for the device "EPIGUARD". The FDA issued a decision of Substantially Equivalent on April 27, 2005. The device falls under product code JXL (Block, Bite), a Class II device regulated under 21 CFR 882.5070.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2005
Date Received
January 27, 2005
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 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)
  • K992269 — VENTIL-A ORAL PROTECTOR (October 25, 1999)
  • 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)

FDA data resources