Rolence

GUDID 04713909450604

ROLENCE ENTERPRISE INC.

Ultrasonic dental scaling/debridement system handpiece

• Primary Device ID: 04713909450604
• NIH Device Record Key: 8cfe0c65-7c0b-47de-867e-4f1423ccce10
• Commercial Distribution Discontinuation: 2016-11-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Rolence
• Version Model Number: MS-30 HS
• Company DUNS: 656096658
• Company Name: ROLENCE ENTERPRISE INC.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04713909450604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040396

FDA Product Code

• ELC: Scaler, Ultrasonic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-21

On-Brand Devices [Rolence]

• 04713909450604: MS-30 HS
• 04713909450482: Q-LUX
• 04713909450475: CU-80
• 04713909450468: CU-100RLC
• 04713909450451: CU-100A
• 04713909450628: XR-01