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FDA 510(k)

ORTHO IMPLANT AND ACCESSORIES

K-Number: K982509 · 1998-09-30

ApplicantStraumann USA
Decision Date1998-09-30
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO IMPLANT AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 1998-09-30 under 510(k) number K982509. 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 ORTHO IMPLANT AND ACCESSORIES?

ORTHO IMPLANT AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is Straumann USA. The 510(k) number is K982509.

When did ORTHO IMPLANT AND ACCESSORIES receive FDA 510(k) clearance?

ORTHO IMPLANT AND ACCESSORIES received FDA 510(k) clearance on 1998-09-30, under 510(k) number K982509.

Who is the listed applicant for ORTHO IMPLANT AND ACCESSORIES?

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 ORTHO IMPLANT AND ACCESSORIES?

The FDA product code for ORTHO IMPLANT AND ACCESSORIES is OAT.

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Other records listing Straumann USA as applicant

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Related Devices (Code: OAT)

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.

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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