Cleared Traditional

K022492 - PULPDENT SEMI-GEL ETCH

K022492 is an FDA 510(k) clearance for PULPDENT SEMI-GEL ETCH, manufactured by Pulpdent Corporation. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K022492 · Pulpdent Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
74d
Days
Class 2
Risk

K022492 is an FDA 510(k) clearance for the PULPDENT SEMI-GEL ETCH. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pulpdent Corporation (Watertown, US). The FDA issued a Cleared decision on October 11, 2002 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pulpdent Corporation devices

FDA 510(k) Submission Details - K022492

510(k) Number K022492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2002
Decision Date October 11, 2002
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 127d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBF Material, Tooth Shade, Resin

All 784
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K022492.
GRADIA DIRECT
K023814 · GC America, Inc. · Jan 2003
CLEARFIL AP-X PLT
K023002 · Kuraray Medical, Inc. · Oct 2002
CLEARFIL AP-X PLT INTRO KIT
K022999 · Kuraray Medical, Inc. · Oct 2002
TWINKY STAR
K022797 · Voco GmbH · Oct 2002
PULPDENT GLAZE
K020432 · Pulpdent Corporation · Apr 2002
UNIFIL FLOW
K020342 · GC America, Inc. · Mar 2002