Cleared Abbreviated

K073047 - APROXI 1100 AND 4000 SERIES DENTAL INLAYS

K073047 is an FDA 510(k) clearance for APROXI 1100 AND 4000 SERIES DENTAL INLAYS, manufactured by Aproxi Aps. The device is a Class 2 Dental device with product code EBF cleared through the Abbreviated 510(k) pathway after a 283-day FDA review.

K073047 · Aproxi Aps · Dental device
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Aug 2008
Decision
283d
Days
Class 2
Risk

K073047 is an FDA 510(k) clearance for the APROXI 1100 AND 4000 SERIES DENTAL INLAYS. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Aproxi Aps (Vaerlose, DK). The FDA issued a Cleared decision on August 7, 2008 after a review of 283 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Aproxi Aps devices

FDA 510(k) Submission Details - K073047

510(k) Number K073047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2007
Decision Date August 07, 2008
Days to Decision 283 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 127d · This submission: 283d
Pathway characteristics
Standards-based clearance path.

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 727
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K073047.
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