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FDA 510(k)

BIOCRYL X

K-Number: K083479 · 2009-02-27

ApplicantGreat Lakes Orthodontics, Ltd.
Decision Date2009-02-27
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOCRYL X is the device name listed in this FDA 510(k) record. The listed applicant is Great Lakes Orthodontics, Ltd.. It received FDA 510(k) clearance on 2009-02-27 under 510(k) number K083479. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCRYL X?

BIOCRYL X is a medical device that received FDA 510(k) clearance on 2009-02-27. The listed applicant is Great Lakes Orthodontics, Ltd.. The 510(k) number is K083479.

When did BIOCRYL X receive FDA 510(k) clearance?

BIOCRYL X received FDA 510(k) clearance on 2009-02-27, under 510(k) number K083479.

Who is the listed applicant for BIOCRYL X?

The FDA 510(k) record lists Great Lakes Orthodontics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCRYL X?

The FDA product code for BIOCRYL X is EBI.

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Other records listing Great Lakes Orthodontics, Ltd. as applicant

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Related Devices (Code: EBI)

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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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