Cleared Traditional

K191836 - Ceramill A-Splint

K191836 · Amann Girrbach AG · Dental device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K191836

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.

MQC Device Classification - Class 0,

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 56
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