Well-Pex

GUDID 08809254454216

Calcium Hydroxide with Iodoform; Well-Pex 0.5 X 1syringe

VERICOM CO., LTD.

Endodontic filling/sealing material

• Primary Device ID: 08809254454216
• NIH Device Record Key: 619b1e28-91c9-47fb-82e8-4eb9c9d1b1c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Well-Pex
• Version Model Number: WP105-S000
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809254454216 [Primary]

FDA Product Code

• KIF: Resin, Root Canal Filling

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: 2020-02-27
• Device Publish Date: 2020-02-19

Devices Manufactured by VERICOM CO., LTD.

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• 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