Dimension Penta L

FDA 510(k) K000595 · Espe Dental AG

Substantially Equivalent

510(k) numberK000595

Submission

Device name
Dimension Penta L
Applicant
Espe Dental AG
Bavaria D-82228 Seefeld, DE
Received
February 22, 2000
Decision date
April 5, 2000
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 Dimension Penta L cleared by the FDA?

Dimension Penta L (K000595) received a 510(k) decision of Substantially Equivalent on April 5, 2000, 43 days after the submission was received.

What is the product code of K000595?

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