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FDA 510(k)

IDEAL 1 ORTHODONTIC BAND CEMENT

K-Number: K040375 · 2004-04-02

ApplicantDentsply Intl.
Decision Date2004-04-02
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IDEAL 1 ORTHODONTIC BAND CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2004-04-02 under 510(k) number K040375. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IDEAL 1 ORTHODONTIC BAND CEMENT?

IDEAL 1 ORTHODONTIC BAND CEMENT is a medical device that received FDA 510(k) clearance on 2004-04-02. The listed applicant is Dentsply Intl.. The 510(k) number is K040375.

When did IDEAL 1 ORTHODONTIC BAND CEMENT receive FDA 510(k) clearance?

IDEAL 1 ORTHODONTIC BAND CEMENT received FDA 510(k) clearance on 2004-04-02, under 510(k) number K040375.

Who is the listed applicant for IDEAL 1 ORTHODONTIC BAND CEMENT?

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

What is the FDA product code for IDEAL 1 ORTHODONTIC BAND CEMENT?

The FDA product code for IDEAL 1 ORTHODONTIC BAND CEMENT is DYH.

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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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