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FDA 510(k)

TRIAD ORTHODONTIC GEL

K-Number: K882482 · 1988-08-12

ApplicantDentsply Intl.
Decision Date1988-08-12
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRIAD ORTHODONTIC GEL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1988-08-12 under 510(k) number K882482. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRIAD ORTHODONTIC GEL?

TRIAD ORTHODONTIC GEL is a medical device that received FDA 510(k) clearance on 1988-08-12. The listed applicant is Dentsply Intl.. The 510(k) number is K882482.

When did TRIAD ORTHODONTIC GEL receive FDA 510(k) clearance?

TRIAD ORTHODONTIC GEL received FDA 510(k) clearance on 1988-08-12, under 510(k) number K882482.

Who is the listed applicant for TRIAD ORTHODONTIC GEL?

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 TRIAD ORTHODONTIC GEL?

The FDA product code for TRIAD ORTHODONTIC GEL is EBI.

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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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