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FDA 510(k)

CONCEPT HP ADD-ON; CONCEPT HP ENAMEL

K-Number: K033773 · 2004-01-15

ApplicantIvoclar Vivadent, AG
Decision Date2004-01-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CONCEPT HP ADD-ON; CONCEPT HP ENAMEL 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 2004-01-15 under 510(k) number K033773. 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 CONCEPT HP ADD-ON; CONCEPT HP ENAMEL?

CONCEPT HP ADD-ON; CONCEPT HP ENAMEL is a medical device that received FDA 510(k) clearance on 2004-01-15. The listed applicant is Ivoclar Vivadent, AG. The 510(k) number is K033773.

When did CONCEPT HP ADD-ON; CONCEPT HP ENAMEL receive FDA 510(k) clearance?

CONCEPT HP ADD-ON; CONCEPT HP ENAMEL received FDA 510(k) clearance on 2004-01-15, under 510(k) number K033773.

Who is the listed applicant for CONCEPT HP ADD-ON; CONCEPT HP ENAMEL?

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 CONCEPT HP ADD-ON; CONCEPT HP ENAMEL?

The FDA product code for CONCEPT HP ADD-ON; CONCEPT HP ENAMEL is EBF.

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Related Devices (Code: EBF)

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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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