Cleared Abbreviated

PROVISIONAL INLAY/ONLAY KIT (K052800) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K052800 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
155d
Days
Class 2
Risk

K052800 is an FDA 510(k) clearance for the PROVISIONAL INLAY/ONLAY KIT. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on March 7, 2006 after a review of 155 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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 Dmg USA, Inc. devices

Submission Details

510(k) Number K052800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2005
Decision Date March 07, 2006
Days to Decision 155 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 127d · This submission: 155d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
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 - EBG Crown And Bridge, Temporary, Resin

All 188
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