510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871493Substantially Equivalent

Denti-Tray(tm)

Advanced Medical, Inc., Huntington Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871493 is the FDA 510(k) clearance record for DENTI-TRAY(TM), a class I device, cleared for Advanced Medical, Inc. on under FDA product code EKW (Broach, Endodontic). FDA records list 3 510(k) clearances for Advanced Medical, Inc., from to . As of , FDA records show no recalls naming K871493.

Clearance record

Decision date
Received
(69 days to decision)
Product code
EKW Broach, Endodontic
Regulation
21 CFR 872.4565
Device class
Class I
Review panel
Dental
Applicant
Advanced Medical, Inc. 17744 Sampson Ln.-Unit 7, Huntington Beach CA
Third party review
No

Clearances, product code EKW

Trailing 12 months

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

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