UltraPrint-Dental Temp C&B UV

FDA 510(k) K213643 · Guangzhou Heygears IMC., Inc.

Substantially Equivalent

510(k) numberK213643

Submission

Device name
UltraPrint-Dental Temp C&B UV
Applicant
Guangzhou Heygears IMC., Inc.
Guangzhou, CN
Received
November 18, 2021
Decision date
January 14, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EBG – Crown And Bridge, Temporary, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3770
Specialty
Dental

Other 510(k)s with product code EBG

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K261261Dura-ArchEBG · Traditional Hangzhou SHINING3D Dental Technology Co., Ltd.04/17/2026SE
K253380“FLNT Base” and “FLNT Temp”EBG · Traditional Liaoning Upcera Co., Ltd.03/02/2026SE
K251271TempFIT Temporary Crown and Bridge ResinEBG · Traditional Rizhao Huge Biomaterials Company, Ltd.06/23/2025SE
K243370DentaTOOTHEBG · Traditional Asiga Pty, Ltd.05/05/2025SE
K243621Evoblock, PerléonEBG · Traditional Evoden Indústria Comércio Importação E Exportação04/22/2025SE
K243951TEMP MASTER, PMMA-based dental resinEBG · Traditional Taiwan Dental Materials Co., Ltd.02/21/2025SE
K242559Digital TempEBG · Traditional Sprintray, Inc.11/26/2024SE
K231859PrimmaArtEBG · Traditional Dentscare Ltda11/26/2024SE
K240538Premium Teeth ResinEBG · Traditional Formlabs Ohio, Inc.07/19/2024SE
K241226Fixtemp® C&B 4:1EBG · Special Dreve Denatmid GmbH05/31/2024SE

More from Dreve Denatmid GmbH

510(k)DeviceDecision
K261626UltraPrint Flexible Denture UVEBI · Traditional 08/13/2026SE
K253798UltraPrint-Dental Hard Splint UVMQC · Traditional 03/02/2026SE
K253324UltraPrint-Dental Denture UVEBI · Traditional 11/20/2025SE

Questions and answers

When was UltraPrint-Dental Temp C&B UV cleared by the FDA?

UltraPrint-Dental Temp C&B UV (K213643) received a 510(k) decision of Substantially Equivalent on January 14, 2022, 57 days after the submission was received.

What is the product code of K213643?

The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.