510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863638Substantially Equivalent

Gutta Percha Points

Endodent, Inc., Monrovia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863638 is the FDA 510(k) clearance record for GUTTA PERCHA POINTS, a class I device, cleared for Endodent, Inc. on under FDA product code EKM (Gutta-Percha). FDA records list 3 510(k) clearances for Endodent, Inc., from to . As of , FDA records show no recalls naming K863638.

Clearance record

Decision date
Received
(43 days to decision)
Product code
EKM Gutta-Percha
Regulation
21 CFR 872.3850
Device class
Class I
Review panel
Dental
Applicant
Endodent, Inc. 135 E. Chestnut Ave., Monrovia CA
Third party review
No

Clearances, product code EKM

Trailing 12 months

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

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