Home / 510(k) Clearances / K960663

510(k) K960663

UNIVERSAL BITE BLOCK by B&B Medical Technologies, Inc. — Product Code JXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1996
Date Received
February 16, 1996
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 B&B Medical Technologies, Inc.

  • K030396 — OMNI~NEB; OMNI~MAX (May 7, 2004)
  • K980407 — HOPE NEBULIZER (May 27, 1998)
  • K945816 — QUICK-LOCK (January 13, 1995)
  • K944324 — SURE-LOCK VENTILATOR TUBING HOLDER (November 4, 1994)
  • K935171 — STABILTRACH (December 2, 1993)
  • K925386 — ADHESIVE E.T. TAPE (April 19, 1993)
  • K923690 — MINI HEART (October 20, 1992)
  • K913015 — HEART NEBULIZER FLOWMETER ADAPTOR (November 20, 1991)
  • K913753 — BODAI NEO2 -SAFE AIRWAY PRESSURE CAP (October 23, 1991)
  • K913000 — HEART NEBULIZER POLE CLAMP (August 2, 1991)

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)
  • 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)