510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K901050Substantially Equivalent

No-Stick Composite Instrument Dip

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

K901050 is the FDA 510(k) clearance record for NO-STICK COMPOSITE INSTRUMENT DIP, a class II device, cleared for Pulpdent Corp. on under FDA product code EBD (Coating, Filling Material, Resin). FDA records list 110 510(k) clearances for Pulpdent Corp., from to . As of , FDA records show no recalls naming K901050.

Clearance record

Decision date
Received
(45 days to decision)
Product code
EBD Coating, Filling Material, Resin
Regulation
21 CFR 872.3310
Device class
Class II
Review panel
Dental
Applicant
Pulpdent Corp. 80 Oakland St., Watertown MA
Third party review
No

Clearances, product code EBD

Trailing 12 months
1 clearance under product code EBD in the twelve months to November 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260