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FDA 510(k)

ITI DISTANCE SYSTEM

K-Number: K931993 · 1994-04-26

ApplicantThe Straumann Co.
Decision Date1994-04-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ITI DISTANCE 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 1994-04-26 under 510(k) number K931993. 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 ITI DISTANCE SYSTEM?

ITI DISTANCE SYSTEM is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is The Straumann Co.. The 510(k) number is K931993.

When did ITI DISTANCE SYSTEM receive FDA 510(k) clearance?

ITI DISTANCE SYSTEM received FDA 510(k) clearance on 1994-04-26, under 510(k) number K931993.

Who is the listed applicant for ITI DISTANCE 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 ITI DISTANCE SYSTEM?

The FDA product code for ITI DISTANCE SYSTEM is DZE.

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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.

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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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