CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)

• K Number: K002693
• Device Name: CBW BRIDGE SYSTEM (CONSISTING OF CBW ANDCHORS, CBW MICRO-HANDPIECE AND BURS)
• Manufacturer: CBS INTL. B.V.
• Date Cleared: 2000-11-09 ( 72 days)
• Product Code: EBL
• Regulation Number: 872.3740

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 872.3740 Retentive and splinting pin.

(a)
Identification. A retentive and splinting pin is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be placed permanently in a tooth to provide retention and stabilization for a restoration, such as a crown, or to join two or more teeth together.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9

Summary

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