Straumann Temporary Coping

FDA 510(k) K041070 · The Straumann Co.

Substantially Equivalent

510(k) numberK041070

Submission

Device name
Straumann Temporary Coping
Applicant
The Straumann Co.
Waltham, MA, US
Received
April 26, 2004
Decision date
July 23, 2004
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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Questions and answers

When was Straumann Temporary Coping cleared by the FDA?

Straumann Temporary Coping (K041070) received a 510(k) decision of Substantially Equivalent on July 23, 2004, 88 days after the submission was received.

What is the product code of K041070?

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