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510(k) K890355

DENTAL X-RAY BITE BLOCK by Bite-A-Block — Product Code EGZ

K890355 is an FDA 510(k) premarket notification submitted by Bite-A-Block for the device "DENTAL X-RAY BITE BLOCK". The FDA issued a decision of Substantially Equivalent on June 12, 1989. The device falls under product code EGZ (Holder, Film, X-Ray), a Class I device regulated under 21 CFR 872.1905.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1989
Date Received
January 24, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Film, X-Ray
Device Class
Class I
Regulation Number
872.1905
Review Panel
DE
Submission Type

Other clearances for product code EGZ

  • K913160 — ID-TAB (September 6, 1991)
  • K913168 — SALIBAG (September 6, 1991)
  • K853451 — TROLL-BITE (January 21, 1986)
  • K852170 — EZX YELLOW, BLUE OR ORANGE (September 5, 1985)
  • K853005 — S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM (August 13, 1985)
  • K813378 — UNI-BITE DENTAL X-RAY FILM HOLDER (January 29, 1982)
  • K801079 — KWIX-BITE X-RAY FILM HOLDER (May 20, 1980)

FDA data resources