510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K896663Substantially Equivalent

Endo-Prep

Pulpdent Corporation, Watertown MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896663 is the FDA 510(k) clearance record for ENDO-PREP, a class I device, cleared for Pulpdent Corp. on under FDA product code EKM (Gutta-Percha). FDA records list 110 510(k) clearances for Pulpdent Corp., from to . As of , FDA records show no recalls naming K896663.

Clearance record

Decision date
Received
(82 days to decision)
Product code
EKM Gutta-Percha
Regulation
21 CFR 872.3850
Device class
Class I
Review panel
Dental
Applicant
Pulpdent Corp. 80 Oakland St., Watertown MA
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EKM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260