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FDA 510(k)

DIRECT BONDED BRACKET REMOVER

K-Number: K832301 · 1983-08-31

ApplicantNorthwest Orthopedics
Decision Date1983-08-31
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIRECT BONDED BRACKET REMOVER is the device name listed in this FDA 510(k) record. The listed applicant is Northwest Orthopedics. It received FDA 510(k) clearance on 1983-08-31 under 510(k) number K832301. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECT BONDED BRACKET REMOVER?

DIRECT BONDED BRACKET REMOVER is a medical device that received FDA 510(k) clearance on 1983-08-31. The listed applicant is Northwest Orthopedics. The 510(k) number is K832301.

When did DIRECT BONDED BRACKET REMOVER receive FDA 510(k) clearance?

DIRECT BONDED BRACKET REMOVER received FDA 510(k) clearance on 1983-08-31, under 510(k) number K832301.

Who is the listed applicant for DIRECT BONDED BRACKET REMOVER?

The FDA 510(k) record lists Northwest Orthopedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIRECT BONDED BRACKET REMOVER?

The FDA product code for DIRECT BONDED BRACKET REMOVER is JCX.

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Related Devices (Code: JCX)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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