Cleared Traditional

K191836 - Ceramill A-Splint

K191836 · Amann Girrbach AG · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2019
Decision
164d
Days
-
Risk

K191836 is an FDA 510(k) clearance for the Ceramill A-Splint. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Amann Girrbach AG (Koblach, AT). The FDA issued a Cleared decision on December 20, 2019 after a review of 164 days - an extended review cycle.

This device falls under the Dental FDA review panel. 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 Amann Girrbach AG devices

Submission Details

510(k) Number K191836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2019
Decision Date December 20, 2019
Days to Decision 164 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
37d slower than avg
Panel avg: 127d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

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 - MQC Mouthguard, Prescription

All 41
Devices cleared under the same product code (MQC) and FDA review panel - the closest regulatory comparables to K191836.
Night Guard
K202465 · 3D Diagnostix, Inc. · Nov 2020
V-Print splint
K201091 · Voco GmbH · Nov 2020
Thermoforming Sheet Materials
K200125 · Erkodent Erich Kopp GmbH · Oct 2020
KeyPrint KeySplint Soft
K183598 · Keystone Industries · Nov 2019
The POD
K182820 · Advanced Facialdontics, LLC · Jul 2019
VeriSplint
K190107 · Whip Mix Corporation · Jul 2019