Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar Titanium

FDA 510(k) K112280 · Straumann USA

Substantially Equivalent

510(k) numberK112280

Submission

Device name
Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar Titanium
Applicant
Straumann USA
Andover, MA, US
Received
August 9, 2011
Decision date
November 16, 2011
Decision
Substantially Equivalent (SESE)
Type
Special 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 Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar Titanium cleared by the FDA?

Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar Titanium (K112280) received a 510(k) decision of Substantially Equivalent on November 16, 2011, 99 days after the submission was received.

What is the product code of K112280?

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