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FDA 510(k)

ENDOSSEOUS DENTAL IMPLANT

K-Number: K971578 · 1997-06-30

ApplicantStraumann USA
Decision Date1997-06-30
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDOSSEOUS DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Straumann USA. It received FDA 510(k) clearance on 1997-06-30 under 510(k) number K971578. 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 ENDOSSEOUS DENTAL IMPLANT?

ENDOSSEOUS DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1997-06-30. The listed applicant is Straumann USA. The 510(k) number is K971578.

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

ENDOSSEOUS DENTAL IMPLANT received FDA 510(k) clearance on 1997-06-30, under 510(k) number K971578.

Who is the listed applicant for ENDOSSEOUS DENTAL IMPLANT?

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 ENDOSSEOUS DENTAL IMPLANT?

The FDA product code for ENDOSSEOUS DENTAL IMPLANT is DZE.

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Other records listing Straumann USA as applicant

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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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