Corrected-V.P.S.

FDA 510(k) K914178 · Jeneric/Pentron, Inc.

Substantially Equivalent

510(k) numberK914178

Submission

Device name
Corrected-V.P.S.
Applicant
Jeneric/Pentron, Inc.
Wallingford, CT, US
Received
September 18, 1991
Decision date
April 28, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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 Corrected-V.P.S. cleared by the FDA?

Corrected-V.P.S. (K914178) received a 510(k) decision of Substantially Equivalent on April 28, 1992, 223 days after the submission was received.

What is the product code of K914178?

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