CanalPro

GUDID 10840016202053

Kit containing the following: (1) CanalPro Endo-Ice Green (1) HySolate Latex Dental Dam Black printed medium 152x152, 36 pcs (1) MicroMega K-Files B6 n008 L25 Sterile (1) MicroMega K-Files B6 n010 L25 Sterile (1) HyFlex EDM NiTi File Finishing Set, 25mm, 3 pcs (1) CanalPro NAOCL 6% 480 ML (1) Guttapercha points HyFlex EDM OGSF (1) HyFlex EDM Guttapercha Points Assortment, 60 pcs (1) Paper points HyFlex EDM OGSF 30/.04 (1) HyFlex Paper Points EDM Assortment, 100 pcs (1) Motor CanalPro X-Move (5) HyFlex EDM OGSF Sequence, 25mm, 4pcs (1) HyFlex EDM 40/.04 Finisher File, 25mm (1) Paper points HyFlex .04 #40 (1) Guttapercha points HyFlex EDM .04 #40 (5) B5 One RECI n25 6% L25 P. PACK Sterile (1) CanalPro EndoUltra Motor (1) CanalPro EDTA 480ML (1) CanalPro Side-Port Tips, 30ga, 100/bag (1) ROEKO GuttaFlow 2 Standard Set, 5 ml

COLTENE/WHALEDENT INC

Cryogenic spray, dental

• Primary Device ID: 10840016202053
• NIH Device Record Key: 957744db-d41e-4be0-b237-2fb73d467a72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CanalPro
• Version Model Number: ENDOBUNDLEXMOV
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT INC
• Device Count: 25
• 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: 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 Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 101 KiloPascal
• Storage Environment Temperature: Between 65 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840016202056 [Primary]
GS1	10840016202053 [Unit of Use]

FDA Product Code

• EAT: Tester, Pulp

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: 2026-02-18
• Device Publish Date: 2026-02-10

On-Brand Devices [CanalPro]

• D661600235260: Endo-Ice Green
• D661600111780: CanalPro Syringe Station
• 10840016202053: Kit containing the following: (1) CanalPro Endo-Ice Green (1) HySolate Latex Dental Dam Black pr