Kwikkmodel

FDA 510(k) K001414 · R-Dental Dentalerzeugnisse GmbH

Substantially Equivalent

510(k) numberK001414

Submission

Device name
Kwikkmodel
Applicant
R-Dental Dentalerzeugnisse GmbH
Hamburg, DE
Received
May 4, 2000
Decision date
August 9, 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 Kwikkmodel cleared by the FDA?

Kwikkmodel (K001414) received a 510(k) decision of Substantially Equivalent on August 9, 2000, 97 days after the submission was received.

What is the product code of K001414?

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