Assure Plus

GUDID 00817645020184

Assure Plus 2ml (Plus2ml)

Six Month Smiles

Orthodontic bracket adhesive

• Primary Device ID: 00817645020184
• NIH Device Record Key: 393441ca-49e7-4838-9a6b-7807eff483ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure Plus
• Version Model Number: 908R
• Company DUNS: 081365847
• Company Name: Six Month Smiles
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817645020184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K895522

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, Resin

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: 2021-02-15
• Device Publish Date: 2021-02-05

Devices Manufactured by Six Month Smiles

• 00817645020207 - Indirect Bonding Tray: 2023-03-24
• 00817645020191 - Porcelain Conditioner: 2021-02-16 Porcelain Conditioner
• 00817645020184 - Assure Plus: 2021-02-15Assure Plus 2ml (Plus2ml)
• 00817645020184 - Assure Plus: 2021-02-15 Assure Plus 2ml (Plus2ml)
• 00817645020177 - 6MS Aligners: 2019-07-25 Dental Aligners
• 00817645020009 - OrthoFlow®: 2018-11-16 OrthoFlow® - Indirect Bond 1.5g (Indirect Bonding)
• 00817645020016 - OrthoMax®: 2018-11-16 OrthoMax® - Direct Bond 5g (Direct Bonding)
• 00817645020023 - Lucid-Lok™: 2018-11-16 Lucid-Lok™ Composite Clearlet (Pack of 10)
• 00817645020030 - Lucid-Lok™: 2018-11-16 Lucid-Lok™ .022 Composite Bracket 5 Set Carousel w/Metal Molar Tubes