Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004

FDA 510(k) K042658 · Nobel Biocare Uas, Inc.

Substantially Equivalent

510(k) numberK042658

Submission

Device name
Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004
Applicant
Nobel Biocare Uas, Inc.
Yorba Linda,, CA, US
Received
September 28, 2004
Decision date
October 20, 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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K260564DESS Dental Smart SolutionsNHA · Traditional Terrats Medical SL06/09/2026SE
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More from Hiossen, Inc.

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K041876Nobeldirect Od ImplantDZE · Traditional 08/20/2004SE
K041312Nobelrondo Dental Ceramic-AluminaEIH · Traditional 07/23/2004SE
K041275Procera Abutment OctagonNHA · Traditional 05/27/2004SE
K040573Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236NHA · Traditional 04/28/2004SE
K033724Nobel Biocare Centric Post, Models 31234, 31235 and 31236NHA · Traditional 02/23/2004SE
K031345Nobel Direct, Models 30937, 30938DZE · Traditional 07/24/2003SE
K030257Nobel Perfect Implant SystemDZE · Special 02/10/2003SE
K023952Replace One Piece Implant, Ha, Replace One Piece Implant, TiuniteDZE · Traditional 01/16/2003SE

Questions and answers

When was Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 cleared by the FDA?

Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 (K042658) received a 510(k) decision of Substantially Equivalent on October 20, 2004, 22 days after the submission was received.

What is the product code of K042658?

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