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510(k) K924333

THE DAVIS DISPOSABLE PROTECTIVE SPLINT by Ora-Gard, Inc. — Product Code JXL

K924333 is an FDA 510(k) premarket notification submitted by Ora-Gard, Inc. for the device "THE DAVIS DISPOSABLE PROTECTIVE SPLINT". The FDA issued a decision of Substantially Equivalent on April 23, 1993. 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 23, 1993
Date Received
August 27, 1992
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)
  • K050188 — EPIGUARD (April 27, 2005)
  • 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)
  • K924304 — BITE BLOCK (April 6, 1993)

FDA data resources