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We Can Create Unique Designs Springs that Are Outside Of The Industry Standard.

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www.fda.gov

Wire Torque Test measures the torsional force required to break a bonded bracket when a rectangular wire is twisted in the wire l T test results showed compa l cket strengths, with the Fast Braces® wire torque test averaging 3,473 gm Force, and the predicate device averaging 3,333 gm Force before breakage occurred.

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Dentistry — Mercury and alloys for dental amalgam — Amendment 1: Requirements for marking and manufacturer's instructions concerning mercury 95.99 ISO/TC 106/SC 1

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0 ~~Orthodontic Design and Production, Inc.

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CDB Corp

CDB began with one man's fascination with ceramic. That fascination sparked a revolution in the bracket industry, proclaiming the arrival of aesthetic ceramic brackets. With orthodontic and dental manufacturers as partners, rather than competitors, CDB Corporation entered the industry, and immediately began gaining a global presence.

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Medical Device Exemptions 510(k) and GMP Requirements

Introduction. Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote.

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Video - oodental.cn

Established in 2015, OO Dental is a high-tech R&D enterprise focusing on self-developed innovation in orthodontic Industry. At present, we've obtained more than 100 patents and our products have already been approved by CE, FDA and ISO 13485.

Dental Devices | FDA

These devices are used to maintain dental health and treat dental problems when they occur. Join the FDA for a Webinar about Dental Device Premarket Submissions The FDA will host a webinar about ...

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Our Policy. It is our policy to use this commitment to provide Orthodontic products that meet our customer’s’ requirements and to comply with ISO 13485, FDA, MDD, CMDR, HSA and other globally recognized standards and accepted industry practices. It will be Executive Management’s responsibility to implement and provide the resources to meet...

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ...

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510(k) Summary 17 23i1) - Food and Drug Administration

ClarityTm Advanced Ceramic Brackets are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.

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