510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K884316Substantially Equivalent

Occlusal Harmony Impression Tray

Advantage Dental Co., Auburn Hills MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884316 is the FDA 510(k) clearance record for OCCLUSAL HARMONY IMPRESSION TRAY, a class I device, cleared for Advantage Dental Co. on under FDA product code EHY (Tray, Impression, Preformed). FDA records list one 510(k) clearance for Advantage Dental Co. As of , FDA records show no recalls naming K884316.

Clearance record

Decision date
Received
(70 days to decision)
Product code
EHY Tray, Impression, Preformed
Regulation
21 CFR 872.6880
Device class
Class I
Review panel
Dental
Applicant
Advantage Dental Co. 3051 E. Pontiac Rd., Auburn Hills MI
Third party review
No

Clearances, product code EHY

Trailing 12 months

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

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