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FDA 510(k)

SYNTEC ORTHODONTIC MINI SCREW

K-Number: K090476 · 2009-06-18

ApplicantSyntec Scientific Corp.
Decision Date2009-06-18
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SYNTEC ORTHODONTIC MINI SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Syntec Scientific Corp.. It received FDA 510(k) clearance on 2009-06-18 under 510(k) number K090476. 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 SYNTEC ORTHODONTIC MINI SCREW?

SYNTEC ORTHODONTIC MINI SCREW is a medical device that received FDA 510(k) clearance on 2009-06-18. The listed applicant is Syntec Scientific Corp.. The 510(k) number is K090476.

When did SYNTEC ORTHODONTIC MINI SCREW receive FDA 510(k) clearance?

SYNTEC ORTHODONTIC MINI SCREW received FDA 510(k) clearance on 2009-06-18, under 510(k) number K090476.

Who is the listed applicant for SYNTEC ORTHODONTIC MINI SCREW?

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

What is the FDA product code for SYNTEC ORTHODONTIC MINI SCREW?

The FDA product code for SYNTEC ORTHODONTIC MINI SCREW is OAT.

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Other records listing Syntec Scientific Corp. 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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