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FDA 510(k)

OSSEOSPEED TM PROFILE SYSTEM

K-Number: K080156 · 2008-09-17

ApplicantAstra Tech AB
Decision Date2008-09-17
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSEOSPEED TM PROFILE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Astra Tech AB. It received FDA 510(k) clearance on 2008-09-17 under 510(k) number K080156. 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 OSSEOSPEED TM PROFILE SYSTEM?

OSSEOSPEED TM PROFILE SYSTEM is a medical device that received FDA 510(k) clearance on 2008-09-17. The listed applicant is Astra Tech AB. The 510(k) number is K080156.

When did OSSEOSPEED TM PROFILE SYSTEM receive FDA 510(k) clearance?

OSSEOSPEED TM PROFILE SYSTEM received FDA 510(k) clearance on 2008-09-17, under 510(k) number K080156.

Who is the listed applicant for OSSEOSPEED TM PROFILE SYSTEM?

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

What is the FDA product code for OSSEOSPEED TM PROFILE SYSTEM?

The FDA product code for OSSEOSPEED TM PROFILE SYSTEM is DZE.

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Other records listing Astra Tech 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.

K121810OSSEOSPEED ANGLED ABUTMENT EVK120414OSSEOSPEED PLUSK113424LOFRIC SINGLE USE URINARY CATHETERK111287ASTRA TECH IMPLANT SYSTEMK101005ASTRA TECH IMPLANT SYSTEM, NEW COMPONENTK101732ASTRA TECH IMPLANT SYSTEM

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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

View on FDA Database →

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

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