Friadent Cercon and Ankylos Cercon Balance Abutments

FDA 510(k) K072730 · Dentsply Intl.

Substantially Equivalent

510(k) numberK072730

Submission

Device name
Friadent Cercon and Ankylos Cercon Balance Abutments
Applicant
Dentsply Intl.
York, PA, US
Received
September 26, 2007
Decision date
March 27, 2008
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 Friadent Cercon and Ankylos Cercon Balance Abutments cleared by the FDA?

Friadent Cercon and Ankylos Cercon Balance Abutments (K072730) received a 510(k) decision of Substantially Equivalent on March 27, 2008, 183 days after the submission was received.

What is the product code of K072730?

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