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FDA 510(k)

MODIFICATION TO ITI DENTAL IMPLANT SYSTEM

K-Number: K003271 · 2001-03-20

ApplicantInstitut Straumann AG
Decision Date2001-03-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ITI DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2001-03-20 under 510(k) number K003271. 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 MODIFICATION TO ITI DENTAL IMPLANT SYSTEM?

MODIFICATION TO ITI DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-03-20. The listed applicant is Institut Straumann AG. The 510(k) number is K003271.

When did MODIFICATION TO ITI DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO ITI DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 2001-03-20, under 510(k) number K003271.

Who is the listed applicant for MODIFICATION TO ITI DENTAL IMPLANT SYSTEM?

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

What is the FDA product code for MODIFICATION TO ITI DENTAL IMPLANT SYSTEM?

The FDA product code for MODIFICATION TO ITI DENTAL IMPLANT SYSTEM is DZE.

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Related Devices (Code: DZE)

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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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