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FDA 510(k)

STRAUMANN DENTAL IMPLANT SYSTEM

K-Number: K083550 · 2009-02-26

ApplicantStraumann USA
Decision Date2009-02-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STRAUMANN DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 2009-02-26 under 510(k) number K083550. 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 STRAUMANN DENTAL IMPLANT SYSTEM?

STRAUMANN DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2009-02-26. The listed applicant is Straumann USA. The 510(k) number is K083550.

When did STRAUMANN DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

STRAUMANN DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2009-02-26, under 510(k) number K083550.

Who is the listed applicant for STRAUMANN DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for STRAUMANN DENTAL IMPLANT SYSTEM?

The FDA product code for STRAUMANN DENTAL IMPLANT SYSTEM is DZE.

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Other records listing Straumann USA as applicant

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K151328PURE Ceramic ImplantsK130724CODIAGNOSTIX IMPLANT PLANNING SOFTWAREK130808STRAUMANN HEALING ABUTMENTS, HEALING CAPS, CLOSURE SCREWSK122855TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTSK121131BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MMK113606NNC GOLD ABUTMENT FOR BRIDGES

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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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