RN Synocta Ucla Gold Abutment for the Straumann Dental Implant

FDA 510(k) K041295 · Institut Straumann AG

Substantially Equivalent

510(k) numberK041295

Submission

Device name
RN Synocta Ucla Gold Abutment for the Straumann Dental Implant
Applicant
Institut Straumann AG
Waltham, MA, US
Received
May 14, 2004
Decision date
May 24, 2004
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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More from Hiossen, Inc.

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Questions and answers

When was RN Synocta Ucla Gold Abutment for the Straumann Dental Implant cleared by the FDA?

RN Synocta Ucla Gold Abutment for the Straumann Dental Implant (K041295) received a 510(k) decision of Substantially Equivalent on May 24, 2004, 10 days after the submission was received.

What is the product code of K041295?

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