Smile Stretcher

Basic Information

• Brand Name: Smile Stretcher
• Primary DI: 00850017524002
• Version / Model: BSS1
• Company Name: STRAIGHT SMILE LLC
• Labeler DUNS: 081010579
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-02
• Public Version: 1
• Public Version Date: 2022-06-10
• Public Version Status: New
• Public Device Record Key: f24c7af8-08bd-43c4-b8b8-9dbb3fb81120

Device Description

Device to retract the lips/cheeks to facilitate viewing of the teeth.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
EIF	Accessories, Retractor, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63817	Dental cheek retractor, home-use	A hands-free, self-retaining frame intended to be used in the home by a patient to retract the lips/cheeks to facilitate viewing of the teeth (e.g., to allow photographs to be taken and sent to a healthcare professional). It is a synthetic polymer device designed to be placed in and around the lips/cheeks; it is not intended to be placed between the teeth (i.e., not a mouth gag). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850017524002	GS1