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FDA 510(k)

MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS

K-Number: K090260 · 2009-02-26

ApplicantStraumann Manufacturing, Inc.
Decision Date2009-02-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Straumann Manufacturing, Inc.. It received FDA 510(k) clearance on 2009-02-26 under 510(k) number K090260. 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 MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS?

MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2009-02-26. The listed applicant is Straumann Manufacturing, Inc.. The 510(k) number is K090260.

When did MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS receive FDA 510(k) clearance?

MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS received FDA 510(k) clearance on 2009-02-26, under 510(k) number K090260.

Who is the listed applicant for MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS?

The FDA 510(k) record lists Straumann Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS?

The FDA product code for MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS 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 Straumann Manufacturing, Inc. 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.

K092814STRAUMANN DENTAL ABUTMENTSK080239P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGSK070478P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALING ABUTMENT (CAP)

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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