Assure Plus

GUDID 00817645020184

Assure Plus 2ml (Plus2ml)

Six Month Smiles

Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive Orthodontic bracket adhesive 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