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FDA 510(k)

ORTHO-KEV APPLIANCE REINFORCING SYSTEM

K-Number: K895714 · 1989-12-21

ApplicantAmerican Orthodontics
Decision Date1989-12-21
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO-KEV APPLIANCE REINFORCING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-12-21 under 510(k) number K895714. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO-KEV APPLIANCE REINFORCING SYSTEM?

ORTHO-KEV APPLIANCE REINFORCING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-12-21. The listed applicant is American Orthodontics. The 510(k) number is K895714.

When did ORTHO-KEV APPLIANCE REINFORCING SYSTEM receive FDA 510(k) clearance?

ORTHO-KEV APPLIANCE REINFORCING SYSTEM received FDA 510(k) clearance on 1989-12-21, under 510(k) number K895714.

Who is the listed applicant for ORTHO-KEV APPLIANCE REINFORCING SYSTEM?

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 ORTHO-KEV APPLIANCE REINFORCING SYSTEM?

The FDA product code for ORTHO-KEV APPLIANCE REINFORCING SYSTEM is EBI.

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Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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