510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801079Substantially Equivalent

Kwix-Bite X-Ray Film Holder

Henry Schein, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801079 is the FDA 510(k) clearance record for KWIX-BITE X-RAY FILM HOLDER, a class I device, cleared for Henry Schein, Inc. on under FDA product code EGZ (Holder, Film, X-Ray). FDA records list 8 510(k) clearances for Henry Schein, Inc., from to . As of , FDA records show no recalls naming K801079.

Clearance record

Decision date
Received
(13 days to decision)
Product code
EGZ Holder, Film, X-Ray
Regulation
21 CFR 872.1905
Device class
Class I
Review panel
Dental
Applicant
Henry Schein, Inc. 803 N. Front St. Suite 3, Mchenry IL
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