Dentsply Sirona 60665900

GUDID D010606659001

Compules Tips Gun

Dentsply De Trey GmbH

Dental material cartridge-plunging applicator, single-component

• Primary Device ID: D010606659001
• NIH Device Record Key: 38060306-d14c-4080-a9ce-75ea3eeccecd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dentsply Sirona
• Version Model Number: 60665900
• Catalog Number: 60665900
• Company DUNS: 315471722
• Company Name: Dentsply De Trey GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D010606659001 [Primary]
HIBCC	D010K1027640 [Direct Marking]

FDA Product Code

• DZN: INSTRUMENTS, DENTAL HAND

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: 2023-08-18
• Device Publish Date: 2023-08-10

Devices Manufactured by Dentsply De Trey GmbH

• D0106425400 - TPH Spectra ST: 2024-03-06 TPH Spectra ST Effects is a visible light-cured, radiopaque, composite restorative for anterior and posterior restorations and c
• D0106425410 - TPH Spectra ST: 2024-03-06 TPH Spectra ST and TPH Spectra ST Effects are visible light-cured, radiopaque, composite restorative for anterior and posterior
• D0106425420 - TPH Spectra ST: 2024-03-06 TPH Spectra ST Effects Compules Tips Intro Kit is a visible light-cured, radiopaque, composite restorative for anterior and post
• D0106425430 - TPH Spectra ST: 2024-03-06 TPH Spectra ST Effects Compules Tips Refill D1 is a visible light-cured, radiopaque, composite restorative for anterior and post
• D0106425440 - TPH Spectra ST: 2024-03-06 TPH Spectra ST Effects Compules Tips Refill D3 is a visible light-cured, radiopaque, composite restorative for anterior and post
• D0106425450 - TPH Spectra ST: 2024-03-06 TPH Spectra ST Effects Compules Tips Refill E1 is a visible light-cured, radiopaque, composite restorative for anterior and post
• D0106425100 - TPH Spectra ST flow: 2024-03-05 TPH Spectra ST flow in Compula is a visible light cured, radiopaque composite resin restorative material with flow characteristi
• D0106425110 - TPH Spectra ST flow: 2024-03-05 TPH Spectra ST flow Compula Refill A1 is a visible light cured, radiopaque composite resin restorative material with flow charac