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FDA 510(k)

MULTILINK AUTOMIX

K-Number: K123397 · 2013-01-31

ApplicantIvoclar Vivadent, AG
Decision Date2013-01-31
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MULTILINK AUTOMIX is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, AG. It received FDA 510(k) clearance on 2013-01-31 under 510(k) number K123397. 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 MULTILINK AUTOMIX?

MULTILINK AUTOMIX is a medical device that received FDA 510(k) clearance on 2013-01-31. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K123397.

When did MULTILINK AUTOMIX receive FDA 510(k) clearance?

MULTILINK AUTOMIX received FDA 510(k) clearance on 2013-01-31, under 510(k) number K123397.

Who is the listed applicant for MULTILINK AUTOMIX?

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

What is the FDA product code for MULTILINK AUTOMIX?

The FDA product code for MULTILINK AUTOMIX is EBF.

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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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