Cleared Traditional

K013510 - POINT 4 MODIFIED

K013510 is the FDA 510(k) clearance for POINT 4 MODIFIED by Sybron Dental Specialties, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K013510 · Sybron Dental Specialties, Inc. · Dental device
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Jan 2002
Decision
88d
Days
Class 2
Risk

K013510 is an FDA 510(k) clearance for the POINT 4 MODIFIED. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on January 18, 2002 after a review of 88 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 Sybron Dental Specialties, Inc. devices

Submission Details

510(k) Number K013510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2001
Decision Date January 18, 2002
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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 479
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K013510.
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