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FDA 510(k)

ADAPTABLE CLASS III MASK

K-Number: K861424 · 1986-05-29

ApplicantGreat Lakes Orthodontics, Ltd.
Decision Date1986-05-29
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADAPTABLE CLASS III MASK 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 1986-05-29 under 510(k) number K861424. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADAPTABLE CLASS III MASK?

ADAPTABLE CLASS III MASK is a medical device that received FDA 510(k) clearance on 1986-05-29. The listed applicant is Great Lakes Orthodontics, Ltd.. The 510(k) number is K861424.

When did ADAPTABLE CLASS III MASK receive FDA 510(k) clearance?

ADAPTABLE CLASS III MASK received FDA 510(k) clearance on 1986-05-29, under 510(k) number K861424.

Who is the listed applicant for ADAPTABLE CLASS III MASK?

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 ADAPTABLE CLASS III MASK?

The FDA product code for ADAPTABLE CLASS III MASK is DZB.

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Other records listing Great Lakes Orthodontics, Ltd. 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.

K172765Smart Moves CompleteK150702Exceed TxK083479BIOCRYL XK041718KELES FACEMASKK040881METACRYLK033632VARIFLEX

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Related Devices (Code: DZB)

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.

K202855Orthodontic FacemaskIta.O Italian Orthodontic System S.R.L.K162543Reverse Pull Adjustable FacemaskSawbros Industries Pvt., Ltd.K111169PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMFKwang Myung Daicom, Inc.K103019KJ MASKKj Meditech Co., Ltd.K052553NITOM LOCKING FACEBOWRussell Samuels Orthodontic DesignK051751EQUA-PULL SAFETY RELEASE MODULEOrtho Technology

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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