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FDA 510(k)

ORTHODONTIC WRAP-AROUND HAWLEY RETAINER

K-Number: K891484 · 1989-04-14

ApplicantAmerican Orthodontics
Decision Date1989-04-14
Product CodeEJF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHODONTIC WRAP-AROUND HAWLEY RETAINER is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 1989-04-14 under 510(k) number K891484. 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 ORTHODONTIC WRAP-AROUND HAWLEY RETAINER?

ORTHODONTIC WRAP-AROUND HAWLEY RETAINER is a medical device that received FDA 510(k) clearance on 1989-04-14. The listed applicant is American Orthodontics. The 510(k) number is K891484.

When did ORTHODONTIC WRAP-AROUND HAWLEY RETAINER receive FDA 510(k) clearance?

ORTHODONTIC WRAP-AROUND HAWLEY RETAINER received FDA 510(k) clearance on 1989-04-14, under 510(k) number K891484.

Who is the listed applicant for ORTHODONTIC WRAP-AROUND HAWLEY RETAINER?

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 WRAP-AROUND HAWLEY RETAINER?

The FDA product code for ORTHODONTIC WRAP-AROUND HAWLEY RETAINER is EJF.

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Related Devices (Code: EJF)

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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