G-CAM

GUDID 08445644001365

95 Monochroma 30NA3

GRAPHENANO DENTAL SL.

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 08445644001365
• NIH Device Record Key: 7372c8dc-648d-4c5b-b3a7-54f1f9e937f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G-CAM
• Version Model Number: GC00078
• 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	08445644001365 [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