P.004 NC Gold Abutment for Crowns

FDA 510(k) K072497 · Institut Straumann AG

Substantially Equivalent

510(k) numberK072497

Submission

Device name
P.004 NC Gold Abutment for Crowns
Applicant
Institut Straumann AG
Andover, MA, US
Received
September 5, 2007
Decision date
September 26, 2007
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 P.004 NC Gold Abutment for Crowns cleared by the FDA?

P.004 NC Gold Abutment for Crowns (K072497) received a 510(k) decision of Substantially Equivalent on September 26, 2007, 21 days after the submission was received.

What is the product code of K072497?

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