SmartBond SM-010

GUDID 07333117000025

Gestenco International AB

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: 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