DenFil

GUDID 08809254450409

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 3ml x 1 syringe

VERICOM CO., LTD.

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• Primary Device ID: 08809254450409
• NIH Device Record Key: 6f24b1c8-f0be-40ef-ac09-0ee663056bc5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DenFil
• Version Model Number: DF104-A000
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809254450409 [Primary]

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2024-02-16
• Device Publish Date: 2016-11-01

On-Brand Devices [DenFil ]

• 08809254450966: Resin-based dental restorative material ; DenFil A1/A2/A3/A3.5/B1/B2(each 0.25g x 10 capsules),
• 08809254450423: Resin-based dental restorative material ; DenFil A1/A2/A3/A3.5/C2(each 4g x 1syringe), BC Plus 5
• 08809254450416: Resin-based dental restorative material ; DenFil A2/A3/A3.5/B2/B3(each 4g x 1syringe), BC Plus 5
• 08809254450409: Resin-based dental restorative material ; DenFil A1/A2/A3/A3.5/B2(each 4g x 1syringe), BC Plus 5