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FDA 510(k)

AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM

K-Number: K982088 · 1998-09-04

ApplicantOrtho Kinetics Corp.
Decision Date1998-09-04
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM 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 1998-09-04 under 510(k) number K982088. 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 AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM?

AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM is a medical device that received FDA 510(k) clearance on 1998-09-04. The listed applicant is Ortho Kinetics Corp.. The 510(k) number is K982088.

When did AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM receive FDA 510(k) clearance?

AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM received FDA 510(k) clearance on 1998-09-04, under 510(k) number K982088.

Who is the listed applicant for AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM?

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 AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM?

The FDA product code for AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM is DZB.

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Other records listing Ortho Kinetics Corp. as applicant

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K980436CLASS III REVERSE PULL FACEMASKK980245NITOM LOCKING FACEBOWK980864POWER COINS GLOW IN THE DARK LIGATURESK980151RELEASABLE FORCE MODULEK980195FACEBOWK940410NEW GEAR RELEASABLE HEADGEAR

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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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