Rolence

GUDID 04713909450628

ROLENCE ENTERPRISE INC.

Hand-held intraoral dental x-ray system, digital

• Primary Device ID: 04713909450628
• NIH Device Record Key: 26525f76-c147-46ee-a2c1-1489921f6e61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rolence
• Version Model Number: XR-01
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04713909450628 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172928

FDA Product Code

• EHD: Unit, X-Ray, Extraoral With Timer

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-04
• Device Publish Date: 2021-04-26

On-Brand Devices [Rolence]

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