Ceramill A-Splint

FDA 510(k) K191836 · Amann Girrbach AG

Substantially Equivalent

510(k) numberK191836

Submission

Device name
Ceramill A-Splint
Applicant
Amann Girrbach AG
Koblach, AT
Received
July 9, 2019
Decision date
December 20, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MQC – Mouthguard, Prescription
Device class
Unclassified

Other 510(k)s with product code MQC

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K253798UltraPrint-Dental Hard Splint UVMQC · Traditional Guangzhou Heygears IMC., Inc.03/02/2026SE
K250743Remvia NightGuardMQC · Traditional Remvia12/05/2025SE
K251252NOBILCAM IMPAK DiscMQC · Traditional Shandong Huge Dental Material Corporation08/01/2025SE
K241729Hard Splint & Thermo-Adaptive SplintMQC · Traditional Whip Mix Corporation03/18/2025SE
K243516Remi Custom Night GuardMQC · Traditional Grindguard, Inc.02/10/2025SE
K241369LIJIA Night GuardMQC · Traditional Lijia, LLC08/22/2024SE
K231775GR Resin System MSIMQC · Traditional Pro3Dure Medical08/08/2024SE
K241311Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B)…MQC · Traditional Bernhard Förster GmbH08/02/2024SE
K240463Slow Wave DS8 (SWDS802)MQC · Traditional Slow Wave, Inc.06/04/2024SE
K231793RODIN 3D Resin SPLINT, Hard/FlexMQC · Traditional Belport Company, Inc., Gingi-Pak03/26/2024SE

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Questions and answers

When was Ceramill A-Splint cleared by the FDA?

Ceramill A-Splint (K191836) received a 510(k) decision of Substantially Equivalent on December 20, 2019, 164 days after the submission was received.

What is the product code of K191836?

The FDA product code is MQC – Mouthguard, Prescription, a Unclassified device.