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FDA 510(k)

BRANEMARK INTEGRATION BIOHELIX IMPLANTS

K-Number: K090005 · 2009-05-19

ApplicantBranemark Integration AB
Decision Date2009-05-19
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BRANEMARK INTEGRATION BIOHELIX IMPLANTS 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 2009-05-19 under 510(k) number K090005. 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 BIOHELIX IMPLANTS?

BRANEMARK INTEGRATION BIOHELIX IMPLANTS is a medical device that received FDA 510(k) clearance on 2009-05-19. The listed applicant is Branemark Integration AB. The 510(k) number is K090005.

When did BRANEMARK INTEGRATION BIOHELIX IMPLANTS receive FDA 510(k) clearance?

BRANEMARK INTEGRATION BIOHELIX IMPLANTS received FDA 510(k) clearance on 2009-05-19, under 510(k) number K090005.

Who is the listed applicant for BRANEMARK INTEGRATION BIOHELIX IMPLANTS?

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 BIOHELIX IMPLANTS?

The FDA product code for BRANEMARK INTEGRATION BIOHELIX IMPLANTS is DZE.

Related Clinical Trials

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.

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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.

K040643BRANEMARK INTEGRATION DENTAL IMPLANT AND ACCESSORIESK021355ENDOSSEOUS 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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