TPH Spectra ST 642542

GUDID D0106425420

TPH Spectra ST Effects Compules Tips Intro Kit is a visible light-cured, radiopaque, composite restorative for anterior and posterior restorations and cosmetic and functional reshaping of primary and permanent teeth.

Dentsply De Trey GmbH

Dental composite resin

• Primary Device ID: D0106425420
• NIH Device Record Key: c0864c2f-5fda-4394-abe6-8b442242b00a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TPH Spectra ST
• Version Model Number: 642542
• Catalog Number: 642542
• Company DUNS: 315471722
• Company Name: Dentsply De Trey GmbH
• Device Count: 28
• 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: true
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight and protect from moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Do not freeze.
• Storage Environment Temperature: Between 2 Degrees Celsius and 28 Degrees Celsius
• 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	D0106425420 [Unit of Use]
HIBCC	D0106425421 [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: 2024-03-06
• Device Publish Date: 2024-02-27

On-Brand Devices [TPH Spectra ST]

• D0106425450: TPH Spectra ST Effects Compules Tips Refill E1 is a visible light-cured, radiopaque, composite r
• D0106425440: TPH Spectra ST Effects Compules Tips Refill D3 is a visible light-cured, radiopaque, composite r
• D0106425430: TPH Spectra ST Effects Compules Tips Refill D1 is a visible light-cured, radiopaque, composite r
• D0106425420: TPH Spectra ST Effects Compules Tips Intro Kit is a visible light-cured, radiopaque, composite r
• D0106425410: TPH Spectra ST and TPH Spectra ST Effects are visible light-cured, radiopaque, composite restora
• D0106425400: TPH Spectra ST Effects is a visible light-cured, radiopaque, composite restorative for anterior