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FDA 510(k)

BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES

K-Number: K040643 · 2004-04-07

ApplicantBranemark Integration AB
Decision Date2004-04-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Branemark Integration AB. It received FDA 510(k) clearance on 2004-04-07 under 510(k) number K040643. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES?

BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2004-04-07. The listed applicant is Branemark Integration AB. The 510(k) number is K040643.

When did BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES receive FDA 510(k) clearance?

BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES received FDA 510(k) clearance on 2004-04-07, under 510(k) number K040643.

Who is the listed applicant for BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES?

The FDA 510(k) record lists Branemark Integration AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES?

The FDA product code for BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIES is DZE.

Related Clinical Trials

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Other records listing Branemark Integration AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090005BRANEMARK INTEGRATION BIOHELIX IMPLANTSK021355ENDOSSEOUS IMPLANT

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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