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FDA 510(k)

THE STRAUMANN ORTHO IMPLANT SYSTEM

K-Number: K040469 · 2004-04-30

ApplicantThe Straumann Co.
Decision Date2004-04-30
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE STRAUMANN ORTHO IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Straumann Co.. It received FDA 510(k) clearance on 2004-04-30 under 510(k) number K040469. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE STRAUMANN ORTHO IMPLANT SYSTEM?

THE STRAUMANN ORTHO IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-30. The listed applicant is The Straumann Co.. The 510(k) number is K040469.

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

THE STRAUMANN ORTHO IMPLANT SYSTEM received FDA 510(k) clearance on 2004-04-30, under 510(k) number K040469.

Who is the listed applicant for THE STRAUMANN ORTHO IMPLANT SYSTEM?

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

What is the FDA product code for THE STRAUMANN ORTHO IMPLANT SYSTEM?

The FDA product code for THE STRAUMANN ORTHO IMPLANT SYSTEM is OAT.

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Other records listing The Straumann Co. 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.

K041070STRAUMANN TEMPORARY COPINGK040646STRAUMANN GRANULESK993862MODUS SAGITTAL SPLIT PLATEK962023PLASTIC PROTECTION HEALING CAPSK960634TITANIUM HEALING CAPSK955281ENDOSSEOUS DENTAL IMPLANT & ACCESSORIES

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Related Devices (Code: OAT)

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K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A.K231502Mini ScrewsProimtech Saglik Urunleri Anonim SirketiK231913T-FITTechwin Co., Ltd.K222245ACR Screw SystemBiomaterials Korea, Inc.K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.

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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