Impression Rekit (Small)

GUDID 00850017524033

Elastomeric Impression Material; Putty Base + Catalyst/Hand-mix (Type 0); Impression Kit

STRAIGHT SMILE LLC

Dental impression material kit, single-use

• Primary Device ID: 00850017524033
• NIH Device Record Key: 98339eb2-ef09-49f8-a754-593d795a04de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Impression Rekit (Small)
• Version Model Number: BYTERKS
• Company DUNS: 081010579
• Company Name: STRAIGHT SMILE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8667652327
• Email: support@byteme.com
• Phone: 8667652327
• Email: support@byteme.com
• Phone: 8667652327
• Email: support@byteme.com
• Phone: 8667652327
• Email: support@byteme.com
• Phone: 8667652327
• Email: support@byteme.com
• Phone: 8667652327
• Email: support@byteme.com
• Phone: 8667652327
• Email: support@byteme.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017524033 [Primary]

FDA Product Code

• ELW: Material, Impression

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): 2022-06-10Elastomeric 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