Cleared Traditional

K191843 - Ceramill A-Temp

K191843 is the FDA 510(k) clearance for Ceramill A-Temp by Amann Girrbach AG. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K191843 · Amann Girrbach AG · Dental device
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Optimized for regulatory review, auditing and printing
Oct 2019
Decision
87d
Days
Class 2
Risk

K191843 is an FDA 510(k) clearance for the Ceramill A-Temp. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Amann Girrbach AG (Koblach, AT). The FDA issued a Cleared decision on October 4, 2019 after a review of 87 days - a notably fast clearance cycle.

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: 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 Amann Girrbach AG devices

Submission Details

510(k) Number K191843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2019
Decision Date October 04, 2019
Days to Decision 87 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
40d faster than avg
Panel avg: 127d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Emergo Europe Consulting
Rachel Paul

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EBG Crown And Bridge, Temporary, Resin

All 91
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K191843.
DiaTemp
K192158 · DiaDent Group International · Feb 2020
DENTCA Crown and Bridge
K192806 · Dentca, Inc. · Feb 2020
Portux CAD/CAM Disc
K192153 · New Stetic, SA · Nov 2019
TurboTemp EZ
K191619 · Zest Anchors, LLC · Sep 2019
SmarTemp X1
K190930 · Parkell, Inc. · Sep 2019
MD-Temp Plus
K190724 · Meta Biomed Co., Ltd. · Jul 2019