TPH Spectra ST 642016

GUDID D0106420160

TPH Spectra ST SureSmile Sample Kit is a sample kit for bonded attachments with TPH Spectra ST

Dentsply De Trey GmbH

Dental composite resin

• Primary Device ID: D0106420160
• NIH Device Record Key: 4b343f83-211d-4faa-aa97-ba0884b724f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TPH Spectra ST
• Version Model Number: 642016
• Catalog Number: 642016
• Company DUNS: 315471722
• Company Name: Dentsply De Trey GmbH
• Device Count: 10
• 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

Device Dimensions

• Weight: 0.25 Gram
• Device Size Text, specify: 0
• Weight: 0.25 Gram
• Device Size Text, specify: 0
• Weight: 0.25 Gram
• Device Size Text, specify: 0
• Weight: 0.25 Gram
• Device Size Text, specify: 0

Operating and Storage Conditions

• 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 *Keep out of direct sunlight and protect from moisture
• 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 *Keep out of direct sunlight and protect from moisture

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0106420160 [Unit of Use]
HIBCC	D0106420161 [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: 2025-12-19
• Device Publish Date: 2025-12-11

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
• D0106420160: TPH Spectra ST SureSmile Sample Kit is a sample kit for bonded attachments with TPH Spectra ST