Chewies

GUDID 00850017524132

A tool to assist in seating aligners and retainers around teeth

STRAIGHT SMILE LLC

Orthodontic positioner support kit

• Primary Device ID: 00850017524132
• NIH Device Record Key: 9212f3e6-a4b3-4924-a929-5b12edce318f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chewies
• Version Model Number: BCHW2
• 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: true
• Expiration Date: true
• 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	00850017524132 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

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: 2022-06-10 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