BioSonic

Basic Information

• Brand Name: BioSonic
• Primary DI: D661600142500
• Version / Model: 60014250
• Company Name: COLTENE/WHALEDENT INC
• Labeler DUNS: 622185718
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-03
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 32dc6676-d259-4077-9bdc-be15694f782b

Device Description

SUVI Premier Plus Ultrasonic Scaler

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELC	Scaler, Ultrasonic	Dental	872.4850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36047	Ultrasonic dental scaling/debridement system	An assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D661600142500	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K130137	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep dry
• Type: Storage Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 158 Degrees Fahrenheit