PRO M CLASS

GUDID 08809394971352

The PRO M CLASS is an AC-powered device that includes a "Motor Handpiece","Contra angle Handpiece","Charger unit" and "AC/DC Adaptor" for grinding, cutting, polishing and screw driver work in dental oral use.

SAEYANG MICROTECH CO.,LTD

Dental surgical power tool motor, electric

• Primary Device ID: 08809394971352
• NIH Device Record Key: 971092ba-aab8-4f81-936c-6b727affc32a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRO M CLASS
• Version Model Number: PRO M CLASS
• Company DUNS: 631078094
• Company Name: SAEYANG MICROTECH CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809394971352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213897

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

[08809394971352]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-15
• Device Publish Date: 2023-06-07

Devices Manufactured by SAEYANG MICROTECH CO.,LTD

• 08809394971352 - PRO M CLASS: 2023-06-15The PRO M CLASS is an AC-powered device that includes a "Motor Handpiece","Contra angle Handpiece","Charger unit" and "AC/DC Adaptor" for grinding, cutting, polishing and screw driver work in dental oral use.
• 08809394971352 - PRO M CLASS: 2023-06-15 The PRO M CLASS is an AC-powered device that includes a "Motor Handpiece","Contra angle Handpiece","Charger unit" and "AC/DC Ada
• 08809394970881 - Ki-20: 2020-10-01
• 08809394970997 - Endo E Class: 2020-10-01
• 08809394971345 - Endo A Class: 2020-10-01