MILLENNIUM DENTAL TECHNOLOGIES, INC.

Address:10945 SOUTH ST., SUITE 104-A,CERRITOS,CA,90703,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (1)

Premarket Exempt

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PerioLase - D808VIII1 Catalog Number : VIII

Device Description : The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with varia The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with variable pulse durations. The laser consists of two interconnected sections: the cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system which includes the Fiberflex fiber and Trueflex handpiece.

Device Class : 2

Duns Number: 062754457

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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