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FDA 510(k)

ZAROLAN, DUALAN, TITAN AND SUPERON

K-Number: K891698 · 1989-06-09

ApplicantDent Zar, Inc.
Decision Date1989-06-09
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZAROLAN, DUALAN, TITAN AND SUPERON is the device name listed in this FDA 510(k) record. The listed applicant is Dent Zar, Inc.. It received FDA 510(k) clearance on 1989-06-09 under 510(k) number K891698. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZAROLAN, DUALAN, TITAN AND SUPERON?

ZAROLAN, DUALAN, TITAN AND SUPERON is a medical device that received FDA 510(k) clearance on 1989-06-09. The listed applicant is Dent Zar, Inc.. The 510(k) number is K891698.

When did ZAROLAN, DUALAN, TITAN AND SUPERON receive FDA 510(k) clearance?

ZAROLAN, DUALAN, TITAN AND SUPERON received FDA 510(k) clearance on 1989-06-09, under 510(k) number K891698.

Who is the listed applicant for ZAROLAN, DUALAN, TITAN AND SUPERON?

The FDA 510(k) record lists Dent Zar, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZAROLAN, DUALAN, TITAN AND SUPERON?

The FDA product code for ZAROLAN, DUALAN, TITAN AND SUPERON is EBF.

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Other records listing Dent Zar, Inc. as applicant

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Related Devices (Code: EBF)

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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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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