Telio CAD Abutment Solutions- extra systems

FDA 510(k) K193193 · Ivoclar Vivadent, AG

Substantially Equivalent

510(k) numberK193193

Submission

Device name
Telio CAD Abutment Solutions- extra systems
Applicant
Ivoclar Vivadent, AG
Schaan, LI
Received
November 19, 2019
Decision date
November 16, 2020
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 Telio CAD Abutment Solutions- extra systems cleared by the FDA?

Telio CAD Abutment Solutions- extra systems (K193193) received a 510(k) decision of Substantially Equivalent on November 16, 2020, 363 days after the submission was received.

What is the product code of K193193?

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