N/A

Basic Information

• Brand Name: N/A
• Primary DI: 08809447651521
• Version / Model: DENTA II arm
• Company Name: Lutronic Corporation
• Labeler DUNS: 688282516
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 38ed177d-f628-4fdc-9613-12f32d20b0db

Device Description

DENTA II Articulated Arm (DENTA II arm)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	878.4810	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47878	Dental carbon dioxide laser system	A mains electricity (AC-powered) Light Amplification by Stimulated Emission of Radiation (LASER) device assembly in which input energy is used to excite carbon dioxide (active medium) to emit a beam of intense, coherent, monochromatic electromagnetic (EM) radiation for application in dental procedures, mainly to excise or vaporize tissue in the oral cavity. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It typically emits energy at a wavelength of 10,600 nm (far infrared) to tissues through a handpiece; it may be operated in continuous-wave or pulsed modes.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	8809447651538	GS1	carton box	1	In Commercial Distribution
Primary	08809447651521	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K091320	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 30 – 70 Percent (%) Relative Humidity