510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890355Substantially Equivalent

Dental X-Ray Bite Block

Bite-A-Block, Daly City CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890355 is the FDA 510(k) clearance record for DENTAL X-RAY BITE BLOCK, a class I device, cleared for Bite-A-Block on under FDA product code EGZ (Holder, Film, X-Ray). FDA records list one 510(k) clearance for Bite-A-Block. As of , FDA records show no recalls naming K890355.

Clearance record

Decision date
Received
(139 days to decision)
Product code
EGZ Holder, Film, X-Ray
Regulation
21 CFR 872.1905
Device class
Class I
Review panel
Dental
Applicant
Bite-A-Block P.O. Box 810, Daly City CA
Third party review
No

Clearances, product code EGZ

Trailing 12 months

FDA records hold no clearances under product code EGZ in the trailing twelve months.

FDA records show no clearances under product code EGZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EGZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260