Correct Plus 1

FDA 510(k) K130920 · Pentron Clinical

Substantially Equivalent

510(k) numberK130920

Submission

Device name
Correct Plus 1
Applicant
Pentron Clinical
Orange, CA, US
Received
April 3, 2013
Decision date
July 2, 2013
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 Correct Plus 1 cleared by the FDA?

Correct Plus 1 (K130920) received a 510(k) decision of Substantially Equivalent on July 2, 2013, 90 days after the submission was received.

What is the product code of K130920?

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