TEMP TABS

GUDID D0331430200

FLEXIBLE MATRIX FOR FABRICATING TEMPORARY CROWNS AND BRIDGES AND BITE REGISTRATIONS

DMG AMERICA, LLC

Composite dental impression material

• Primary Device ID: D0331430200
• NIH Device Record Key: 11ced5f2-91bc-4506-b742-9f15f01eedba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEMP TABS
• Version Model Number: 143020
• Company DUNS: 106792427
• Company Name: DMG AMERICA, LLC
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 145 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0331430200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033227

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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: 2025-04-28
• Device Publish Date: 2025-04-18

On-Brand Devices [TEMP TABS]

• D0331430330: FLEXIBLE MATRIX FOR FABRICATING TEMPORARY CROWNS AND BRIDGES AND BITE REGISTRATIONS
• D0331430200: FLEXIBLE MATRIX FOR FABRICATING TEMPORARY CROWNS AND BRIDGES AND BITE REGISTRATIONS