SmartMTA Capsule

GUDID 00819235022189

SmartMTA Capsule - 10 pack

Sprig Oral Health Technologies, Inc.

Hygroscopic dental cement

• Primary Device ID: 00819235022189
• NIH Device Record Key: 220299ce-6092-4738-8cc4-dcc794a63d98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartMTA Capsule
• Version Model Number: R-MTA-C10
• Company DUNS: 029458526
• Company Name: Sprig Oral Health Technologies, Inc.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00819235022189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230797

FDA Product Code

• KIF: Resin, Root Canal Filling

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: 2023-05-26
• Device Publish Date: 2023-05-18

On-Brand Devices [SmartMTA Capsule]

• 00819235022196: SmartMTA Capsule - 20 pack
• 00819235022189: SmartMTA Capsule - 10 pack