FDA 510(k)

ORTHODONTIC COTTON ROLL HOLDERS

K-Number: K891354 · 1989-04-17

Decision Date1989-04-17

Product CodeKHR

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC COTTON ROLL HOLDERS is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-04-17 under 510(k) number K891354. The device is classified under product code KHR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHODONTIC COTTON ROLL HOLDERS?

ORTHODONTIC COTTON ROLL HOLDERS is a medical device that received FDA 510(k) clearance on 1989-04-17. The listed applicant is American Orthodontics. The 510(k) number is K891354.

When did ORTHODONTIC COTTON ROLL HOLDERS receive FDA 510(k) clearance?

ORTHODONTIC COTTON ROLL HOLDERS received FDA 510(k) clearance on 1989-04-17, under 510(k) number K891354.

Who is the listed applicant for ORTHODONTIC COTTON ROLL HOLDERS?

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 ORTHODONTIC COTTON ROLL HOLDERS?

The FDA product code for ORTHODONTIC COTTON ROLL HOLDERS is KHR.

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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.