Cleared Traditional

SCULPTURE PLUS NANO-HYBRID COMPOSITE (K023742) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023742 · Pentron Laboratory Technologies · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
71d
Days
Class 2
Risk

K023742 is an FDA 510(k) clearance for the SCULPTURE PLUS NANO-HYBRID COMPOSITE. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Pentron Laboratory Technologies (Wallingford, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 71 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 Pentron Laboratory Technologies devices

Submission Details

510(k) Number K023742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2002
Decision Date January 17, 2003
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 127d · This submission: 71d
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 195
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