WATER FILLED TEETHER

• K Number: K052105
• Device Name: WATER FILLED TEETHER
• Manufacturer: ROYAL INDUSTRIES (THAILAND) PUBLIC CO. LTD.
• Date Cleared: 2005-10-31 ( 89 days)
• Product Code: KKO
• Regulation Number: 872.5550

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

§ 872.5550 Teething ring.

(a)
Identification. A teething ring is a divice intended for use by infants for medical purposes to soothe gums during the teething process.(b)(1)
Classification. Class I if the teething ring does not contain a fluid, such as water. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.(2) Class II (special controls) if the teething ring contains a fluid, such as water. 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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