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FDA 510(k)

ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR

K-Number: K061266 · 2006-07-31

ApplicantOrtho Organizers, Inc.
Decision Date2006-07-31
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Organizers, Inc.. It received FDA 510(k) clearance on 2006-07-31 under 510(k) number K061266. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR?

ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR is a medical device that received FDA 510(k) clearance on 2006-07-31. The listed applicant is Ortho Organizers, Inc.. The 510(k) number is K061266.

When did ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR receive FDA 510(k) clearance?

ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR received FDA 510(k) clearance on 2006-07-31, under 510(k) number K061266.

Who is the listed applicant for ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR?

The FDA 510(k) record lists Ortho Organizers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR?

The FDA product code for ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR is OAT.

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Other records listing Ortho Organizers, Inc. as applicant

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Related Devices (Code: OAT)

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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