510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K983461Substantially Equivalent

Uni-Flex Resin

Trans-Atlantic Dental, Trenton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K983461 is the FDA 510(k) clearance record for UNI-FLEX RESIN, a class II device, cleared for Trans-Atlantic Dental on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list one 510(k) clearance for Trans-Atlantic Dental. As of , FDA records show no recalls naming K983461.

Clearance record

Decision date
Received
(194 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
Trans-Atlantic Dental 46 Arctic Pkwy., Trenton NJ
510(k) summary
Statement
Third party review
No

Clearances, product code EBI

Trailing 12 months
10 clearances under product code EBI in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EBI, trailing twelve months
MonthClearances
November 20253
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20263
August 20262
September 20260
October 20260