Essentials High Speed Handpiece
4Pages

In alignment with the FDA Guidance Document, Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices (September 24, 2022), End-Users may follow this information to assemble the UDI. 1. For devices without direct markings, users may assemble the UDI information of the product by referencing the serial numbers engraved on the devices itself, in addition to referencing the table listed below. The serial numbers are located on the devices themselves as an engraving and/or name plates. Below are several examples of serial numbers depicted on the products for reference. Example 1. – Essentials E-Type Lowspeed Contra Angle Sheath HS REF: Item Description: Essentials E-Type Lowspeed Contra Angle Sheath Serial Number: Engraved Serial Number Example 2. – Maxima XTEND AX Maintenance System HS REF: 570-1174 Item Description: Maxima XTEND AX Maintenance System Serial Number: 22070019 Serial Numbe

Example 3. – Acclean Ultrasonic Scaler HS REF: Item Description: Acclean Ultrasonic Scaler Serial Number: Serial Number 2. Users may then assemble the UDI using the serial number obtained from step 1 and referencing the corresponding table below with associated part number and GTIN. UDI may be obtained as follows: ‘(01)’GTIN + ‘(21)’SN = UDI. • In example #1, the human-readable UDI Information for 112-7304 will be: (01)00304040058268(21)21120441 In example #2, the human-readable UDI Information for 570-1174 will be: (01)00304040099520(21)22070019 In example #3, the human-readable UDI...

Item Description Essentials C-Type Push-Button Handpiece Essentials C-Type Handpiece Essentials C-Type Mini Push-Button Handpiece Essentials C-Type Mini Handpiece Essentials E-Type Lowspeed System Essentials E-Type Lowspeed 20,000 RPM Motor Essentials E-Type Lowspeed Straight Attachment Essentials E-Type Lowspeed Contra Angle Sheath Maxima XTEND Maintenance Maxima ELITE Handpiece Maxima ELITE Handpiece Mini Precision-Torque 2Cr SS Maxima PRO 2 Highspeed Handpiece Maxima PRO 2L Highspeed Optic Handpiece Maxima PRO 2S Highspeed Swivel Handpiece Maxima XTEND AX Maintenance Essentials Pro 2...

Item Description Master 3 Mini High-Speed HP Master Torque 3 Straight Master Torque 3 Contra Angle Master Torque 3 4:1 Straght f/ Maxima Electric System Maxima Electric Micromotor PDS MaxPro Highspeed Handpiece PDS MaxPro M Highspeed Handpiece MaxPro Highspeed Handpiece MaxPro M Highspeed Handpiece MaxPro L Highspeed Handpiece MaxPro ML Highspeed Handpiece MaxPro M Personalized MaxPro L Personalized Maxima PRO 2L AR Highspeed Handpiece Maxima PRO 2S AR Handpiece Acclean Ultrasonic Scaler Acclean Hygiene Handpiece 2S Acclean Hygiene Handpiece 2 PRO 2-K Lowspeed Attachment Contra Angle Sheath...