510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954637Substantially Equivalent

American Dental Products Tissue Conditioner & Temporary Reliner

American Dental Products, Inc., Medinah IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954637 is the FDA 510(k) clearance record for AMERICAN DENTAL PRODUCTS TISSUE CONDITIONER & TEMPORARY RELINER, a class II device, cleared for American Dental Products, Inc. on under FDA product code EBI (Resin, Denture, Relining, Repairing, Rebasing). FDA records list 23 510(k) clearances for American Dental Products, Inc., from to . As of , FDA records show no recalls naming K954637.

Clearance record

Decision date
Received
(83 days to decision)
Product code
EBI Resin, Denture, Relining, Repairing, Rebasing
Regulation
21 CFR 872.3760
Device class
Class II
Review panel
Dental
Applicant
American Dental Products, Inc. P.O. Box 435, Medinah IL
510(k) summary
Summary
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