SmartBond SM-010

GUDID 07333117000025

Gestenco International AB

Orthodontic bracket adhesive

• Primary Device ID: 07333117000025
• NIH Device Record Key: 077928a1-0af1-461c-b4d4-d6b2e66172cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartBond
• Version Model Number: SM-010
• Catalog Number: SM-010
• Company DUNS: 354936098
• Company Name: Gestenco International AB
• 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	07333117000025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K981036

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-11

On-Brand Devices [SmartBond]

• 07333117000025: SM-010
• 07333117000018: SM-000
• 07333117000049: SM-001
• 07333117000032: SM-002