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FDA 510(k)

TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT

K-Number: K950514 · 1995-03-07

Applicant3M Unitek
Decision Date1995-03-07
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is 3M Unitek. It received FDA 510(k) clearance on 1995-03-07 under 510(k) number K950514. 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 TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT?

TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT is a medical device that received FDA 510(k) clearance on 1995-03-07. The listed applicant is 3M Unitek. The 510(k) number is K950514.

When did TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT receive FDA 510(k) clearance?

TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT received FDA 510(k) clearance on 1995-03-07, under 510(k) number K950514.

Who is the listed applicant for TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT?

The FDA 510(k) record lists 3M Unitek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT?

The FDA product code for TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT is DYH.

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Official Source

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