510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780746Substantially Equivalent

Hygienic Rubber Dam Frame

Hygienic Dental Mfg., Co., the, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780746 is the FDA 510(k) clearance record for HYGIENIC RUBBER DAM FRAME, a class I device, cleared for Hygienic Dental Mfg., Co., The on under FDA product code EJE (Frame, Rubber Dam). FDA records list 6 510(k) clearances for Hygienic Dental Mfg., Co., The, from to . As of , FDA records show no recalls naming K780746.

Clearance record

Decision date
Received
(29 days to decision)
Product code
EJE Frame, Rubber Dam
Regulation
21 CFR 872.6300
Device class
Class I
Review panel
Dental
Applicant
Hygienic Dental Mfg., Co., The 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EJE

Trailing 12 months

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

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