Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow

FDA 510(k) K151399 · Schutz Dental GmbH

Substantially Equivalent

510(k) numberK151399

Submission

Device name
Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow
Applicant
Schutz Dental GmbH
Rosbach, DE
Received
May 26, 2015
Decision date
October 24, 2016
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 Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow cleared by the FDA?

Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow (K151399) received a 510(k) decision of Substantially Equivalent on October 24, 2016, 517 days after the submission was received.

What is the product code of K151399?

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