Protemp H

FDA 510(k) K002364 · Espe Dental AG

Substantially Equivalent

510(k) numberK002364

Submission

Device name
Protemp H
Applicant
Espe Dental AG
Bavaria D-82228 Seefeld, DE
Received
August 3, 2000
Decision date
August 10, 2000
Decision
Substantially Equivalent (SESE)
Type
Special 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

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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

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Questions and answers

When was Protemp H cleared by the FDA?

Protemp H (K002364) received a 510(k) decision of Substantially Equivalent on August 10, 2000, 7 days after the submission was received.

What is the product code of K002364?

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