510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812886Substantially Equivalent

Endodontic Paper Points

United Dental Mfg., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812886 is the FDA 510(k) clearance record for ENDODONTIC PAPER POINTS, a class I device, cleared for United Dental Mfg., Inc. on under FDA product code EKN (Point, Paper, Endodontic). FDA records list 5 510(k) clearances for United Dental Mfg., Inc., from to . As of , FDA records show no recalls naming K812886.

Clearance record

Decision date
Received
(33 days to decision)
Product code
EKN Point, Paper, Endodontic
Regulation
21 CFR 872.3830
Device class
Class I
Review panel
Dental
Applicant
United Dental Mfg., 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