Ceramir CAD/CAM T-BLOCK Universal Enamel

GUDID 09120046326610

5pcs Ceramir CAD/CAM T-BLOCK Universal Enamel (12/14/18)

edelweiss dentistry products gmbh

Dental appliance fabrication material, combination-material

• Primary Device ID: 09120046326610
• NIH Device Record Key: b1b911d7-766e-4243-aa77-ce57c8117a2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramir CAD/CAM T-BLOCK Universal Enamel
• Version Model Number: 805187
• Company DUNS: 300537672
• Company Name: edelweiss dentistry products gmbh
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120046326610 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241131

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: 2024-11-12
• Device Publish Date: 2024-11-04

Devices Manufactured by edelweiss dentistry products gmbh

• 09120046322414 - edelweiss CAD/CAM T-BLOCK Universal Enamel (12/14/18): 2024-11-12 5pcs edelweiss CAD/CAM T-BLOCK Universal Enamel (12/14/18)
• 09120046322421 - edelweiss CAD/CAM C-BLOCK A0 (12/14/18): 2024-11-12 5pcs edelweiss CAD/CAM C-BLOCK A0 (12/14/18)
• 09120046322438 - edelweiss CAD/CAM C-BLOCK A1 (12/14/18): 2024-11-12 5pcs edelweiss CAD/CAM C-BLOCK A1 (12/14/18)
• 09120046322445 - edelweiss CAD/CAM C-BLOCK A2 (12/14/18): 2024-11-12 5pcs edelweiss CAD/CAM C-BLOCK A2 (12/14/18)
• 09120046322452 - edelweiss CAD/CAM C-BLOCK A3 (12/14/18): 2024-11-12 5pcs edelweiss CAD/CAM C-BLOCK A3 (12/14/18)
• 09120046322476 - edelweiss CAD/CAM i-BLOCK (ØS) Universal Enamel: 2024-11-12 5pcs edelweiss CAD/CAM i-BLOCK (ØS) Universal Enamel
• 09120046322483 - edelweiss CAD/CAM i-BLOCK (ØS) A0: 2024-11-12 5pcs edelweiss CAD/CAM i-BLOCK (ØS) A0
• 09120046322490 - edelweiss CAD/CAM i-BLOCK (ØS) A1: 2024-11-12 5pcs edelweiss CAD/CAM i-BLOCK (ØS) A1