FDA 510(k)

UNI-STICK PLASTIC LIGATURES

K-Number: K891331 · 1989-10-16

Decision Date1989-10-16

Product CodeEJF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

UNI-STICK PLASTIC LIGATURES is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-10-16 under 510(k) number K891331. The device is classified under product code EJF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-STICK PLASTIC LIGATURES?

UNI-STICK PLASTIC LIGATURES is a medical device that received FDA 510(k) clearance on 1989-10-16. The listed applicant is American Orthodontics. The 510(k) number is K891331.

When did UNI-STICK PLASTIC LIGATURES receive FDA 510(k) clearance?

UNI-STICK PLASTIC LIGATURES received FDA 510(k) clearance on 1989-10-16, under 510(k) number K891331.

Who is the listed applicant for UNI-STICK PLASTIC LIGATURES?

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

What is the FDA product code for UNI-STICK PLASTIC LIGATURES?

The FDA product code for UNI-STICK PLASTIC LIGATURES is EJF.

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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.