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510(k) K201309

ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium by Mecta Corporation — Product Code JXL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 2021
Date Received
May 15, 2020
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 Mecta Corporation

  • K192834 — MECTA Sigma (April 26, 2020)

Other clearances for product code JXL

  • K221469 — PATI (Protector Against Tongue Injury) (February 22, 2023)
  • 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)
  • K924333 — THE DAVIS DISPOSABLE PROTECTIVE SPLINT (April 23, 1993)
  • K924304 — BITE BLOCK (April 6, 1993)