510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K912820Substantially Equivalent

Polyester Resin Hand Molded Tray

E&D Dental Products, Inc., Westfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K912820 is the FDA 510(k) clearance record for POLYESTER RESIN HAND MOLDED TRAY, a class I device, cleared for E&D Dental Products, Inc. on under FDA product code EBH (Material, Impression Tray, Resin). FDA records list 3 510(k) clearances for E&D Dental Products, Inc., from to . As of , FDA records show no recalls naming K912820.

Clearance record

Decision date
Received
(57 days to decision)
Product code
EBH Material, Impression Tray, Resin
Regulation
21 CFR 872.3670
Device class
Class I
Review panel
Dental
Applicant
E&D Dental Products, Inc. 560 Springfield Ave., Westfield NJ
510(k) summary
Statement
Third party review
No

Clearances, product code EBH

Trailing 12 months

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

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