Smilers

Basic Information

• Brand Name: Smilers
• Primary DI: 03770020010040
• Version / Model: Passive Appliance
• Catalog Number: GOUTPA
• Company Name: BIOTECH DENTAL SMILERS
• Labeler DUNS: 266048588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-04-20
• Public Version: 1
• Public Version Date: 2022-04-28
• Public Version Status: New
• Public Device Record Key: fa7ec04b-57d5-4d12-869e-c8743bef17c0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NXC	Aligner, Sequential	Dental	872.5470	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35310	Orthodontic retainer	An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03770020010040	GS1

Premarket Submissions

Submission Number	Supplement Number
K212961	000