510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800389Substantially Equivalent

Anterior & Post. Restorative Paste Sys.

American Dental Research, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800389 is the FDA 510(k) clearance record for ANTERIOR & POST. RESTORATIVE PASTE SYS., a class II device, cleared for American Dental Research on under FDA product code KLE (Agent, Tooth Bonding, Resin). FDA records list 5 510(k) clearances for American Dental Research. As of , FDA records show no recalls naming K800389.

Clearance record

Decision date
Received
(50 days to decision)
Product code
KLE Agent, Tooth Bonding, Resin
Regulation
21 CFR 872.3200
Device class
Class II
Review panel
Dental
Applicant
American Dental Research 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KLE

Trailing 12 months
8 clearances under product code KLE in the twelve months to October 2026, March 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KLE, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20261
March 20262
April 20261
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260