Coltosol F

FDA 510(k) K031752 · Coltene/Whaledent, Inc.

Substantially Equivalent

510(k) numberK031752

Submission

Device name
Coltosol F
Applicant
Coltene/Whaledent, Inc.
Cuyahoga Falls, OH, US
Received
June 5, 2003
Decision date
August 5, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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Questions and answers

When was Coltosol F cleared by the FDA?

Coltosol F (K031752) received a 510(k) decision of Substantially Equivalent on August 5, 2003, 61 days after the submission was received.

What is the product code of K031752?

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