510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K760983Substantially Equivalent

Endodontic Instruments

Adp Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K760983 is the FDA 510(k) clearance record for ENDODONTIC INSTRUMENTS, a class I device, cleared for Adp Intl., Inc. on under FDA product code EKN (Point, Paper, Endodontic). FDA records list 11 510(k) clearances for Adp Intl., Inc. As of , FDA records show no recalls naming K760983.

Clearance record

Decision date
Received
(25 days to decision)
Product code
EKN Point, Paper, Endodontic
Regulation
21 CFR 872.3830
Device class
Class I
Review panel
Dental
Applicant
Adp Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EKN

Trailing 12 months

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

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