TPH Spectra ST flow 642524

GUDID D0106425240

TPH Spectra ST flow Syringe Refill A4 is a visible light cured, radiopaque composite resin restorative material with flow characteristics that make it ideal for use in anterior and posterior teeth.

Dentsply De Trey GmbH

Dental composite resin

• Primary Device ID: D0106425240
• NIH Device Record Key: 48bd3a6a-2c92-478b-a22a-a3e54705ffd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TPH Spectra ST flow
• Version Model Number: 642524
• Catalog Number: 642524
• Company DUNS: 315471722
• Company Name: Dentsply De Trey GmbH
• Device Count: 2
• DM Exempt: true
• 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

• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0106425240 [Unit of Use]
HIBCC	D0106425241 [Primary]

FDA Product Code

• EBF: Material, tooth shade, 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: 2024-03-05
• Device Publish Date: 2024-02-26

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• D0106425220: TPH Spectra ST flow Syringe Refill A2 is a visible light cured, radiopaque composite resin resto
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• D0106425150: TPH Spectra ST flow Compula Refill A3.5 is a visible light cured, radiopaque composite resin res
• D0106425140: TPH Spectra ST flow Compula Refill A4 is a visible light cured, radiopaque composite resin resto
• D0106425130: TPH Spectra ST flow Compula Refill A3 is a visible light cured, radiopaque composite resin resto
• D0106425120: TPH Spectra ST flow Compula Refill A2 is a visible light cured, radiopaque composite resin resto
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