Smile Stretcher

GUDID 00850017524002

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

STRAIGHT SMILE LLC

Dental cheek retractor, home-use

• Primary Device ID: 00850017524002
• NIH Device Record Key: f24c7af8-08bd-43c4-b8b8-9dbb3fb81120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smile Stretcher
• Version Model Number: BSS1
• Company DUNS: 081010579
• Company Name: STRAIGHT SMILE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017524002 [Primary]

FDA Product Code

• EIF: Accessories, Retractor, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-10
• Device Publish Date: 2022-06-02

Devices Manufactured by STRAIGHT SMILE LLC

• 00850017524200 - Brightbyte Pro (wireless) Whitening Kit: 2023-09-15 [Wireless] LED teeth whitening kit
• 00850017524224 - Portable UV Sanitizer: 2023-03-28 Portable ultraviolet sanitizer case intended to disinfect dental appliances (i.e. aligners, retainers, chewies, toothbrushes)
• 00850017524064 - BrightByte: 2022-10-10 A liquid cleansing agent used to remove small debris from plastic aligners
• 00850017524088 - Brightbyte Pro Whitening Kit: 2022-06-14 LED teeth whitening kit
• 00850017524118 - Brightbyte Pro Refill Pens: 2022-06-14 Whitening and Desensitizing Gel Pens
• 00850017524002 - Smile Stretcher: 2022-06-10Device to retract the lips/cheeks to facilitate viewing of the teeth.
• 00850017524002 - Smile Stretcher: 2022-06-10 Device to retract the lips/cheeks to facilitate viewing of the teeth.
• 00850017524019 - Impression Kit Standard: 2022-06-10 Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit
• 00850017524033 - Impression Rekit (Small): 2022-06-10 Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit