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FDA 510(k)

NEW GEAR RELEASABLE HEADGEAR

K-Number: K940410 · 1994-03-10

ApplicantOrtho Kinetics Corp.
Decision Date1994-03-10
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEW GEAR RELEASABLE HEADGEAR is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Kinetics Corp.. It received FDA 510(k) clearance on 1994-03-10 under 510(k) number K940410. 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 NEW GEAR RELEASABLE HEADGEAR?

NEW GEAR RELEASABLE HEADGEAR is a medical device that received FDA 510(k) clearance on 1994-03-10. The listed applicant is Ortho Kinetics Corp.. The 510(k) number is K940410.

When did NEW GEAR RELEASABLE HEADGEAR receive FDA 510(k) clearance?

NEW GEAR RELEASABLE HEADGEAR received FDA 510(k) clearance on 1994-03-10, under 510(k) number K940410.

Who is the listed applicant for NEW GEAR RELEASABLE HEADGEAR?

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

What is the FDA product code for NEW GEAR RELEASABLE HEADGEAR?

The FDA product code for NEW GEAR RELEASABLE HEADGEAR is DZB.

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Other records listing Ortho Kinetics Corp. 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.

K982088AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEMK980436CLASS III REVERSE PULL FACEMASKK980245NITOM LOCKING FACEBOWK980864POWER COINS GLOW IN THE DARK LIGATURESK980151RELEASABLE FORCE MODULEK980195FACEBOW

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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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