Conquest Smooth Touch

FDA 510(k) K941377 · Jeneric/Pentron, Inc.

Substantially Equivalent

510(k) numberK941377

Submission

Device name
Conquest Smooth Touch
Applicant
Jeneric/Pentron, Inc.
Wallingford, CT, US
Received
March 22, 1994
Decision date
May 3, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EBF – Material, Tooth Shade, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3690
Specialty
Dental

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Questions and answers

When was Conquest Smooth Touch cleared by the FDA?

Conquest Smooth Touch (K941377) received a 510(k) decision of Substantially Equivalent on May 3, 1994, 42 days after the submission was received.

What is the product code of K941377?

The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.