P.004 RC Cares Titanium and Ceramic Abutments

FDA 510(k) K072151 · Straumann USA

Substantially Equivalent

510(k) numberK072151

Submission

Device name
P.004 RC Cares Titanium and Ceramic Abutments
Applicant
Straumann USA
Andover, MA, US
Received
August 3, 2007
Decision date
September 11, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 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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More from Hiossen, Inc.

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K192401Straumann Screw-Retained AbutmentsNHA · Traditional 04/06/2020SE
K190662MRI Compatibility for Existing Straumann Dental Implant SystemsDZE · Traditional 06/17/2019SE
K171784Straumann Dental Implant SystemDZE · Traditional 01/19/2018SE
K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…DZE · Traditional 03/08/2017SE
K151590Straumann RN Gold Abutment for BridgeNHA · Traditional 03/04/2016SE
K151328PURE Ceramic ImplantsDZE · Traditional 01/11/2016SE
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Questions and answers

When was P.004 RC Cares Titanium and Ceramic Abutments cleared by the FDA?

P.004 RC Cares Titanium and Ceramic Abutments (K072151) received a 510(k) decision of Substantially Equivalent on September 11, 2007, 39 days after the submission was received.

What is the product code of K072151?

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