510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K022522Substantially Equivalent

Pulpdent Putty Dam

Pulpdent Corporation, Watertown MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022522 is the FDA 510(k) clearance record for PULPDENT PUTTY DAM, a class I device, cleared for Pulpdent Corporation on under FDA product code EIE (Dam, Rubber). FDA records list 110 510(k) clearances for Pulpdent Corporation, from to . As of , FDA records show no recalls naming K022522.

Clearance record

Decision date
Received
(58 days to decision)
Product code
EIE Dam, Rubber
Regulation
21 CFR 872.6300
Device class
Class I
Review panel
Dental
Applicant
Pulpdent Corporation 80 Oakland St., Watertown MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EIE

Trailing 12 months

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

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