510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994182Substantially Equivalent

Pulpdent Cavity Preparation 1, Pulpdent Cavity Preparation 1 with Fluoride

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

K994182 is the FDA 510(k) clearance record for PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE, a class II device, cleared for Pulpdent Corp. on under FDA product code LBH (Varnish, Cavity). FDA records list 110 510(k) clearances for Pulpdent Corp., from to . As of , FDA records show no recalls naming K994182.

Clearance record

Decision date
Received
(75 days to decision)
Product code
LBH Varnish, Cavity
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Pulpdent Corp. 80 Oakland St., Watertown MA
510(k) summary
Statement
Third party review
No

Clearances, product code LBH

Trailing 12 months
6 clearances under product code LBH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LBH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260