StoneBite and StoneBite scan

Q: What is the product code of K190571?

The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.

FDA 510(k) K190571 · Dreve Dentamid GmbH

Substantially Equivalent

510(k) numberK190571

Submission

Device name: StoneBite and StoneBite scan
Applicant: Dreve Dentamid GmbH
Unna, DE
Received: March 6, 2019
Decision date: November 7, 2019
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: ELW – Material, Impression
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3660
Specialty: Dental

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K222741	DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular…ELW · Traditional	Hdi, Inc.	11/07/2022SE

More from Hdi, Inc.

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K171562	Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax monoELW · Abbreviated	04/13/2018SE
K162408	Nano Varnish, Plaquit, Lightpaint on SurfaceEBD · Traditional	04/05/2018SE
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Questions and answers

When was StoneBite and StoneBite scan cleared by the FDA?

StoneBite and StoneBite scan (K190571) received a 510(k) decision of Substantially Equivalent on November 7, 2019, 246 days after the submission was received.

What is the product code of K190571?

The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.