ROLENCE ENTERPRISE INC. is an ISO 9001, ISO 13485 certified manufacturer of Ultrasonic Scalers. All the products are FDA registered and compliant with EN standard (CE Marking). Conformance to Standards: The MS-50 R1 Ultrasonic Scaler conforms to IEC60601-1-2:2007 and IEC60601-1-1:2006. The device is CE marked corresponding to European Medical Device Directive (93/42/EEC). Supplies and Replacement Parts Contact your local ROLENCE dealer to order supplies or replacement parts. There are no serviceable parts included in the Ultrasonic Scaler. Please contact your dealer to acquire all repairing service and technique supports. CAUTION: EQUIPMENT NOT SUITABLE FOR USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC MIXTURE WITH AIR OR WITH NITROUS OXIDE. CAUTION: U.S FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A DENTAL PROFESSIONAL. Ultrasonic procedure ‧All general supra and subgingival…
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