510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K073209Substantially Equivalent

Maxcem 2

Sybron Dental Specialties, Inc., Orange CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K073209 is the FDA 510(k) clearance record for MAXCEM 2, a class II device, cleared for Kerr Corporation on under FDA product code MZW (Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief). FDA records list 176 510(k) clearances for Sybron Dental Specialties, Inc., from to . As of , FDA records show 3 recalls naming K073209.

Clearance record

Decision date
Received
(76 days to decision)
Product code
MZW Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Kerr Corporation 1717 W. Collins Ave., Orange CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MZW

Trailing 12 months

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

FDA records show no clearances under product code MZW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MZW, 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