G-CAM

GUDID 08445644002164

98.5 Multichroma 30LA1

GRAPHENANO DENTAL SL.

Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic

• Primary Device ID: 08445644002164
• NIH Device Record Key: 4df2634f-1f44-464c-b58b-43c4c705bd0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-CAM
• Version Model Number: GC00309
• Company DUNS: 467167850
• Company Name: GRAPHENANO DENTAL SL.
• 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: true
• Lot Batch: true
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com
• Phone: +34965108102
• Email: info@graphenanodental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08445644002164 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220329

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: 2022-10-31
• Device Publish Date: 2022-10-21

On-Brand Devices [G-CAM]

• 08445644003208: 98.5 Multichroma 18LA3
• 08445644003192: 98.5 Monochroma 24NC2
• 08445644003185: 98.5 Monochroma 18NC2
• 08445644003178: 98.5 Multichroma 22LBL1
• 08445644003161: 98.5 Multichroma 18LA2
• 08445644003154: 95 Multichroma 16LA1
• 08445644003147: 95 Multichroma 22LBL2
• 08445644003130: 95 Multichroma18LA3,5
• 08445644003123: 95 Monochroma 24NTR
• 08445644003116: 95 Monochroma 20NA1
• 08445644003109: 98.5 Multichroma 14LBL2
• 08445644003093: 98.5 Multichroma 14LBL1
• 08445644003086: 95 Monochroma 18NTR
• 08445644003079: 95 Monochroma 24NPINK
• 08445644003062: 95 Multichroma18LA3
• 08445644003055: 95 Multichroma 22LBL1
• 08445644003048: 95 Multichroma 14LC2
• 08445644003031: 98.5 Multichroma 16LA1
• 08445644003024: 98.5 Multichroma 22LB2
• 08445644003017: 98.5 Monochroma 18NBL2
• 08445644003000: 98.5 Monochroma 24NBL2
• 08445644002997: 98.5 Monochroma 24NBL1
• 08445644002980: 98.5 Monochroma 18NBL1
• 08445644002973: 98.5 Multichroma 22LB1
• 08445644002966: 98.5 Multichroma 14LA3
• 08445644002959: 95 Multichroma 14LBL2
• 08445644002942: 95 Multichroma 22LB2
• 08445644002935: 95 Multichroma14LA3,5
• 08445644002928: 95 Monochroma 24NC2
• 08445644002911: 95 Monochroma 18NPINK
• 08445644002904: 98.5 Multichroma 14LB2
• 08445644002898: 98.5 Multichroma 14LB1
• 08445644002881: 95 Monochroma 18NC2
• 08445644002874: 95 Monochroma 24NBL2
• 08445644002867: 95 Multichroma14LA3
• 08445644002850: 95 Multichroma 22LB1
• 08445644002843: 95 Multichroma 14LBL1
• 08445644002836: 98.5 Multichroma 30LC2
• 08445644002829: 98.5 Multichroma 22LA3,5
• 08445644002812: 98.5 Monochroma 18NB2
• 08445644002805: 98.5 Monochroma 24NB2
• 08445644002799: 98.5 Monochroma 24NB1
• 08445644002782: 98.5 Monochroma 18NB1
• 08445644002775: 98.5 Multichroma 22LA3
• 08445644002768: 98.5 Multichroma 30LBL2
• 08445644002751: 95 Multichroma 14LB2
• 08445644002744: 95 Multichroma 22LA3,5
• 08445644002737: 95 Multichroma 30LC2
• 08445644002720: 95 Monochroma 24NBL1
• 08445644002713: 95 Monochroma 18NBL2