Ramitec Penta

FDA 510(k) K952693 · Espe GmbH & Co. Kg.

Substantially Equivalent

510(k) numberK952693

Submission

Device name
Ramitec Penta
Applicant
Espe GmbH & Co. Kg.
Seefeld, DE
Received
June 13, 1995
Decision date
August 18, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 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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Questions and answers

When was Ramitec Penta cleared by the FDA?

Ramitec Penta (K952693) received a 510(k) decision of Substantially Equivalent on August 18, 1995, 66 days after the submission was received.

What is the product code of K952693?

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