Cleared Traditional

K901051 - 22% POLYACRYLIC ACID GEL

K901051 is the FDA 510(k) clearance for 22% POLYACRYLIC ACID GEL by Pulpdent Corp.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K901051 · Pulpdent Corp. · Dental device
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Apr 1990
Decision
56d
Days
Class 2
Risk

K901051 is an FDA 510(k) clearance for the 22% POLYACRYLIC ACID GEL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pulpdent Corp. (Watertown, US). The FDA issued a Cleared decision on April 30, 1990 after a review of 56 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 Corp. devices

Submission Details

510(k) Number K901051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1990
Decision Date April 30, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 127d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 577
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K901051.
EOS INLAY MATERIAL
K896469 · Ivoclar North America, Inc. · May 1990
CONCEPT INLAY/ONLAY
K901396 · Ivoclar North America, Inc. · May 1990
FERMIT TEMPORARY MATERIAL
K896530 · Ivoclar North America, Inc. · May 1990
CORE BUILD UP COMPOSITE
K896950 · Confi-Dental Products Co. · Mar 1990
SEPARATING MEDIUM (POLYVINYL ALCOHOL)
K896653 · Pulpdent Corp. · Feb 1990
DRYING AGENT
K896654 · Pulpdent Corp. · Feb 1990