DenFil Flow

GUDID 08800123811574

Light-Cured Radiopaque Flowable Composite Resin ; DenFil Flow A3 0.5g x 1 syringe, 3 Disposable tips

VERICOM CO., LTD.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 08800123811574
• NIH Device Record Key: 06ededbc-b489-4c21-9bf7-f1bf469ad269
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DenFil Flow
• Version Model Number: FR102-SA33
• Company DUNS: 689698269
• Company Name: VERICOM CO., LTD.
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr
• Phone: +82314412881
• Email: vericom@vericom.co.kr

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800123811574 [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: 2023-08-25
• Device Publish Date: 2023-08-17

Devices Manufactured by VERICOM CO., LTD.

• 08800123812908 - MAZIC Claro Press: 2024-02-29 Glass Ceramic for Press System; LT A3 Size S*5ea
• 08809254450409 - DenFil: 2024-02-16 Resin-based dental restorative material ; DenFil A1/A2/A3/A3.5/B2(each 4g x 1syringe), BC Plus 5ml x 1 bottle, DenFil Etchant-37
• 08809254450416 - DenFil: 2024-02-16 Resin-based dental restorative material ; DenFil A2/A3/A3.5/B2/B3(each 4g x 1syringe), BC Plus 5ml x 1 bottle, DenFil Etchant-37
• 08809254450423 - DenFil: 2024-02-16 Resin-based dental restorative material ; DenFil A1/A2/A3/A3.5/C2(each 4g x 1syringe), BC Plus 5ml x 1 bottle, DenFil Etchant-37
• 08809254450966 - DenFil: 2024-02-16 Resin-based dental restorative material ; DenFil A1/A2/A3/A3.5/B1/B2(each 0.25g x 10 capsules), BC Plus 5ml x 1 bottle, DenFil
• 08809254451895 - BC Plus: 2024-02-16 5th generation Single Component Bonding Agent ; BC Plus 1ml x 1 bottle
• 08809254451918 - BC Plus: 2024-02-16 5th generation Single Component Bonding Agent ; BC Plus 5ml x 1 bottle
• 08800123821368 - MAZIC Claro CAD: 2024-01-31 Glass Ceramic for CAD System; B32, LT A3 Mandrel type*3ea