Cleared Traditional

K200676 - ABRO 1

K200676 is an FDA 510(k) clearance for ABRO 1, manufactured by Zirkonzahn Srl. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K200676 · Zirkonzahn Srl · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2020
Decision
114d
Days
Class 2
Risk

K200676 is an FDA 510(k) clearance for the ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Zirkonzahn Srl (Gais, IT). The FDA issued a Cleared decision on July 8, 2020 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Zirkonzahn Srl devices

FDA 510(k) Submission Details - K200676

510(k) Number K200676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2020
Decision Date July 08, 2020
Days to Decision 114 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
13d faster than avg
Panel avg: 127d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBG Device Classification - Class 2, Special Controls

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 111
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K200676.
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K192022 · DiaDent Group International · Feb 2020