FDA 510(k)

NICKLE-TITANIUM ORTHODONTIC WIRE

K-Number: K891327 · 1989-05-10

Decision Date1989-05-10

Product CodeFJF

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

NICKLE-TITANIUM ORTHODONTIC WIRE is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-05-10 under 510(k) number K891327. The device is classified under product code FJF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICKLE-TITANIUM ORTHODONTIC WIRE?

NICKLE-TITANIUM ORTHODONTIC WIRE is a medical device that received FDA 510(k) clearance on 1989-05-10. The listed applicant is American Orthodontics. The 510(k) number is K891327.

When did NICKLE-TITANIUM ORTHODONTIC WIRE receive FDA 510(k) clearance?

NICKLE-TITANIUM ORTHODONTIC WIRE received FDA 510(k) clearance on 1989-05-10, under 510(k) number K891327.

Who is the listed applicant for NICKLE-TITANIUM ORTHODONTIC WIRE?

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 NICKLE-TITANIUM ORTHODONTIC WIRE?

The FDA product code for NICKLE-TITANIUM ORTHODONTIC WIRE is FJF.

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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.