Primo Dental Laser MD.PRIMO.D.01.03.DEN

GUDID 08059340290024

Max power: 7W Wavelength: 810nm The model Primo Komfort of the family of medical devices "Primo Dental Laser" is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It’s a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts.

MEDENCY SRL

General/multiple surgical diode laser system

• Primary Device ID: 08059340290024
• NIH Device Record Key: df870cf0-9eda-4956-9c57-c2de8022a7c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primo Dental Laser
• Version Model Number: Primo Komfort
• Catalog Number: MD.PRIMO.D.01.03.DEN
• Company DUNS: 436042800
• Company Name: MEDENCY SRL
• 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: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08059340290024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232222

FDA Product Code

• NVK: Laser, Dental, Soft Tissue

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: 2024-04-18
• Device Publish Date: 2024-04-10

On-Brand Devices [Primo Dental Laser]

• 08059340290079: Max power: 10W Wavelength: 450/635/980nm The model Primo Triplo of the family of medical devices
• 08059340290062: Max power: 10W Wavelength: 450/635/810nm The model Primo Triplo of the family of medical devices
• 08059340290055: Max power: 10W Wavelength: 635/810/980nm The model Primo Triplo of the family of medical devices
• 08059340290048: Max power: 3W Wavelength: 450nm The model Primo Blue of the family of medical devices "Primo Den
• 08059340290031: Max power: 2.5W Wavelength: 980nm The model Primo Lite of the family of medical devices "Primo D
• 08059340290024: Max power: 7W Wavelength: 810nm The model Primo Komfort of the family of medical devices "Primo
• 08059340290017: Max power: 10W Wavelength: 940nm The model Primo of the family of medical devices "Primo Dental
• 08059340290000: Max power: 10W Wavelength: 980nm The model Primo of the family of medical devices "Primo Dental