Cleared Traditional

K070191 - ALPHA-CORE DC

K070191 is an FDA 510(k) clearance for ALPHA-CORE DC, manufactured by Dental Technologies, Inc.. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K070191 · Dental Technologies, Inc. · Dental device
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Mar 2007
Decision
44d
Days
Class 2
Risk

K070191 is an FDA 510(k) clearance for the ALPHA-CORE DC. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dental Technologies, Inc. (Lincolnwood, US). The FDA issued a Cleared decision on March 7, 2007 after a review of 44 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 Dental Technologies, Inc. devices

FDA 510(k) Submission Details - K070191

510(k) Number K070191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2007
Decision Date March 07, 2007
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 127d · This submission: 44d
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 690
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