FDA 510(k)

KORN MANDIBULAR ADVANCER

K-Number: K893482 · 1989-10-12

Decision Date1989-10-12

Product CodeEJF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

KORN MANDIBULAR ADVANCER is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K893482. 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 KORN MANDIBULAR ADVANCER?

KORN MANDIBULAR ADVANCER is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is American Orthodontics. The 510(k) number is K893482.

When did KORN MANDIBULAR ADVANCER receive FDA 510(k) clearance?

KORN MANDIBULAR ADVANCER received FDA 510(k) clearance on 1989-10-12, under 510(k) number K893482.

Who is the listed applicant for KORN MANDIBULAR ADVANCER?

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 KORN MANDIBULAR ADVANCER?

The FDA product code for KORN MANDIBULAR ADVANCER 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.