Ketac-Molar Aplicap

FDA 510(k) K960954 · Espe GmbH & Co. Kg.

Substantially Equivalent

510(k) numberK960954

Submission

Device name
Ketac-Molar Aplicap
Applicant
Espe GmbH & Co. Kg.
Seefeld, DE
Received
March 11, 1996
Decision date
May 16, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EMA – Cement, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3275
Specialty
Dental

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K962442Hytac Aplitip/Hytac OsbEBF · Traditional 09/11/1996SE
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Questions and answers

When was Ketac-Molar Aplicap cleared by the FDA?

Ketac-Molar Aplicap (K960954) received a 510(k) decision of Substantially Equivalent on May 16, 1996, 66 days after the submission was received.

What is the product code of K960954?

The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.