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FDA 510(k)

ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS

K-Number: K052245 · 2005-09-23

ApplicantLar Mfg., LLC
Decision Date2005-09-23
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS is the device name listed in this FDA 510(k) record. The listed applicant is Lar Mfg., LLC. It received FDA 510(k) clearance on 2005-09-23 under 510(k) number K052245. 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 ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS?

ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS is a medical device that received FDA 510(k) clearance on 2005-09-23. The listed applicant is Lar Mfg., LLC. The 510(k) number is K052245.

When did ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS receive FDA 510(k) clearance?

ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS received FDA 510(k) clearance on 2005-09-23, under 510(k) number K052245.

Who is the listed applicant for ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS?

The FDA 510(k) record lists Lar Mfg., LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS?

The FDA product code for ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS is NJM.

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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.

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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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