510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K771973Substantially Equivalent

Gingitract

Den-Mat Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K771973 is the FDA 510(k) clearance record for GINGITRACT, a class I device, cleared for Den-Mat Corp. on under FDA product code EIG (Retractor, All Types). FDA records list 29 510(k) clearances for Den-Mat Corp., from to . As of , FDA records show no recalls naming K771973.

Clearance record

Decision date
Received
(21 days to decision)
Product code
EIG Retractor, All Types
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Den-Mat Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code EIG

Trailing 12 months

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

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