ELiTEDENT

GUDID 04713909450581

ROLENCE ENTERPRISE INC.

Ultrasonic dental scaling/debridement system handpiece tip, periodontal

• Primary Device ID: 04713909450581
• NIH Device Record Key: 6d025b62-50ca-43b2-ad13-60f2addd9ea5
• Commercial Distribution Discontinuation: 2021-09-23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELiTEDENT
• Version Model Number: PS-25B
• 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: 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	04713909450581 [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: 2016-09-23

On-Brand Devices [ELiTEDENT]

• 04713909450598: Classic / R1
• 04713909450581: PS-25B
• 04713909450574: Classic / Plus
• 04713909450567: Classic / Dual
• 04713909450550: Classic / Dual
• 04713909450543: Classic / Plus
• 04713909450536: PS-25
• 04713909450529: MS-10B
• 04713909450512: MS-10
• 04713909450444: Q-6B
• 04713909450437: Q-6
• 04713909450420: Q-4W
• 04713909450413: Q-4