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FDA 510(k)

NEO-CLIP ORTHODONTIC BRACKET ACCESSORY

K-Number: K042905 · 2004-11-04

Decision Date2004-11-04
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEO-CLIP ORTHODONTIC BRACKET ACCESSORY is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2004-11-04 under 510(k) number K042905. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEO-CLIP ORTHODONTIC BRACKET ACCESSORY?

NEO-CLIP ORTHODONTIC BRACKET ACCESSORY is a medical device that received FDA 510(k) clearance on 2004-11-04. The listed applicant is Dentsply Intl.. The 510(k) number is K042905.

When did NEO-CLIP ORTHODONTIC BRACKET ACCESSORY receive FDA 510(k) clearance?

NEO-CLIP ORTHODONTIC BRACKET ACCESSORY received FDA 510(k) clearance on 2004-11-04, under 510(k) number K042905.

Who is the listed applicant for NEO-CLIP ORTHODONTIC BRACKET ACCESSORY?

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

What is the FDA product code for NEO-CLIP ORTHODONTIC BRACKET ACCESSORY?

The FDA product code for NEO-CLIP ORTHODONTIC BRACKET ACCESSORY is NJM.

Related Clinical Trials

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.

Other records listing Dentsply Intl. as applicant

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.

View all 279 devices →

Related Devices (Code: NJM)

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.

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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