VITA ENAMIC Implant Solutions (IS)

FDA 510(k) K153645 · Vita Zahnfabrik H.Rauter GmbH Co.

Substantially Equivalent

510(k) numberK153645

Submission

Device name
VITA ENAMIC Implant Solutions (IS)
Applicant
Vita Zahnfabrik H.Rauter GmbH Co.
Bad Sackingen, DE
Received
December 21, 2015
Decision date
June 30, 2016
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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Questions and answers

When was VITA ENAMIC Implant Solutions (IS) cleared by the FDA?

VITA ENAMIC Implant Solutions (IS) (K153645) received a 510(k) decision of Substantially Equivalent on June 30, 2016, 192 days after the submission was received.

What is the product code of K153645?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.