PapaPost Taper Lux

GUDID D661600199090

ParaPost Taper Lux Training Kit

COLTENE/WHALEDENT INC

Root canal post, preformed

• Primary Device ID: D661600199090
• NIH Device Record Key: df3bade6-10d7-4726-b5ca-2be26cfaea89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PapaPost Taper Lux
• Version Model Number: 60019909
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT INC
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840016201820 [Secondary]
HIBCC	D661600199090 [Unit of Use]
HIBCC	D661600199091 [Primary]

FDA Product Code

• ELR: Post, Root Canal

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

[D661600199090]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-06
• Device Publish Date: 2024-11-28

Devices Manufactured by COLTENE/WHALEDENT INC

• D661600185680 - ParaPost Fiber Lux: 2024-12-06 ParaPost Fiber Lux Size 3
• D661600185690 - ParaPost Fiber Lux: 2024-12-06 ParaPost Fiber Lux Size 4
• D661600185700 - ParaPost Fiber Lux: 2024-12-06 ParaPost Fiber Lux Size 4.5
• D661600185710 - ParaPost Fiber Lux: 2024-12-06 ParaPost Fiber Lux Size 5
• D661600185720 - ParaPost Fiber Lux: 2024-12-06 ParaPost Fiber Lux Size 5.5
• D661600185730 - ParaPost Fiber Lux: 2024-12-06 ParaPost Fiber Lux Size 6
• D661600185740 - Tenax Fiber Trans: 2024-12-06 Tenax Fiber Trans Size 1.1
• D6616001857510 - Tenax Fiber Trans: 2024-12-06 Tenax Fiber Trans Size 1.3