Smile Spa

Basic Information

• Brand Name: Smile Spa
• Primary DI: 00850007728151
• Version / Model: 100-0367
• Company Name: Access Dental Lab, LLC
• Labeler DUNS: 054012763
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-19
• Public Version: 2
• Public Version Date: 2021-04-15
• Public Version Status: Update
• Public Device Record Key: eb6159a6-0439-496c-925e-1e73c5a7057f

Device Description

Ultrasonic UV cleaner; smile spa safely cleans: toothbrush heads, dentures, aligners, retainers, mouthguards, nightguards, TMJ appliances, water flosser tips, and more.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• 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
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	880.6150	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44734	Orthodontic appliance automated cleaner	An electromechanical device designed to clean soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. The orthodontic appliances are typically placed in a receptacle and water together with an appropriate cleansing tablet or solution, and cleaned through an automated cycle. An audible signal may alert the user that the program has finished.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850007728151	GS1

Customer Contacts

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