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FDA 510(k)

STRAUMANN EXTRAORAL IMPLANT SYSTEM

K-Number: K990458 · 1999-04-16

ApplicantStraumann USA
Decision Date1999-04-16
Product CodeKCZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STRAUMANN EXTRAORAL 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 1999-04-16 under 510(k) number K990458. The device is classified under product code KCZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRAUMANN EXTRAORAL IMPLANT SYSTEM?

STRAUMANN EXTRAORAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1999-04-16. The listed applicant is Straumann USA. The 510(k) number is K990458.

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

STRAUMANN EXTRAORAL IMPLANT SYSTEM received FDA 510(k) clearance on 1999-04-16, under 510(k) number K990458.

Who is the listed applicant for STRAUMANN EXTRAORAL 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 EXTRAORAL IMPLANT SYSTEM?

The FDA product code for STRAUMANN EXTRAORAL IMPLANT SYSTEM is KCZ.

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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: KCZ)

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.

K951324MAXOL IMAGE II PATIENT MATCHED BREAST PROSTHESISMaxol Limited L.C.K933465COSMETGreat Bay Medical Products, Inc.K932978CALSSIQUE OR MYSTIQUEDekumed, Kunststofftechnik Degler GmbHK932899CLASSIQUEHemispheres Marketing Co. , Ltd.K933668ALMOST U, INC. BREAST PROSTHESISAlmost U., Inc.K921535SUOENA AFFINITY (TM) MODEL #802Coloplast Corp.

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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