510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K961089Substantially Equivalent

Pulpdent Endoprep II

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

K961089 is the FDA 510(k) clearance record for PULPDENT ENDOPREP II, a class I device, cleared for Pulpdent Corp. on under FDA product code EKL (Point, Silver, Endodontic). FDA records list 110 510(k) clearances for Pulpdent Corp., from to . As of , FDA records show no recalls naming K961089.

Clearance record

Decision date
Received
(35 days to decision)
Product code
EKL Point, Silver, Endodontic
Regulation
21 CFR 872.3840
Device class
Class I
Review panel
Dental
Applicant
Pulpdent Corp. 80 Oakland St., Watertown MA
510(k) summary
Summary
Third party review
No

Clearances, product code EKL

Trailing 12 months

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

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