Dental Implant Coping (Prosthetic Accessories to the Iti Dental Implant System)

FDA 510(k) K032498 · Straumann USA

Substantially Equivalent

510(k) numberK032498

Submission

Device name
Dental Implant Coping (Prosthetic Accessories to the Iti Dental Implant System)
Applicant
Straumann USA
Andover, MA, US
Received
August 13, 2003
Decision date
August 27, 2003
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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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
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Questions and answers

When was Dental Implant Coping (Prosthetic Accessories to the Iti Dental Implant System) cleared by the FDA?

Dental Implant Coping (Prosthetic Accessories to the Iti Dental Implant System) (K032498) received a 510(k) decision of Substantially Equivalent on August 27, 2003, 14 days after the submission was received.

What is the product code of K032498?

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