Carmen®

GUDID J011262239300

CARMEN® flash opaque C2-C3, 15 g / dental ceramic material

DENTAURUM GmbH & Co.KG

Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic

• Primary Device ID: J011262239300
• NIH Device Record Key: 8b44d45e-1362-4c97-ab17-89b882c43715
• Commercial Distribution Discontinuation: 2024-01-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Carmen®
• Version Model Number: 262-239-30
• Company DUNS: 315427286
• Company Name: DENTAURUM GmbH & Co.KG
• 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: false
• 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: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com
• Phone: +1(800)523-3946
• Email: info@dentaurum-us.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required
• Special Storage Condition, Specify: Between 0 and 0 *No special storage conditions required

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J011262239300 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011425

FDA Product Code

• EIH: POWDER, PORCELAIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-01-25
• Device Publish Date: 2016-09-15

On-Brand Devices [Carmen®]

• J011264232900: CARMEN® dentin C2, 240 g / dental ceramic material
• J011262342100: Universal paste opaque D2, 3 g / dental ceramic material
• J011262323100: Universal paste opaque B3, 3 g / dental ceramic material
• J011262322100: Universal paste opaque B2, 3 g / dental ceramic material
• J011265354300: CARMEN® incisal opalescent 58, 15 g / dental ceramic material
• J011266451300: CARMEN® Arteline ivory, 15 g / dental ceramic material
• J011265570300: CARMEN® incisal intensive 63, 15 g / dental ceramic material
• J011265350300: CARMEN® incisal opalescent 57, 15 g / dental ceramic material
• J011265299600: CARMEN® neutral transparent, 40 g / dental ceramic material
• J011264221600: CARMEN® dentin B1, 40 g / dental ceramic material
• J011264112600: CARMEN® opaque dentin A2, 40 g / dental ceramic material
• J011262244300: CARMEN® flash opaque D4, 15 g / dental ceramic material
• J011262223300: CARMEN® flash opaque B3, 15 g / dental ceramic material
• J011264212300: CARMEN® dentin A2, 15 g / dental ceramic material
• J011264231600: CARMEN® dentin C1, 40 g / dental ceramic material
• J011264221300: CARMEN® dentin B1, 15 g / dental ceramic material
• J011264470300: CARMEN® dentin intensive orange, 15 g / dental ceramic material
• J011264211300: CARMEN® dentin A1, 15 g / dental ceramic material
• J011264112300: CARMEN® opaque dentin A2, 15 g / dental ceramic material
• J011262100100: CARMEN® flash opaque base material, 4 g / dental ceramic material
• J011269150800: CARMEN® modelling liquid MV, 100ml / dental ceramic material
• J011264221900: CARMEN® dentin B1, 240g / dental ceramic material
• J011265160600: CARMEN® incisal transparent 59, 40 g / dental ceramic material
• J011264212600: CARMEN® dentin A2, 40 g / dental ceramic material
• J011264211600: CARMEN® dentin A1, 40 g / dental ceramic material
• J011262250100: Universal paste opaque, 3 g / dental ceramic material
• J011264223600: CARMEN® dentin B3, 40 g / dental ceramic material
• J011264121300: CARMEN® opaque dentin B1, 15 g / dental ceramic material
• J011264113600: CARMEN® opaque dentin A3, 40 g / dental ceramic material
• J011262424600: CARMEN® / CCS powder opaque B4, 40 g / dental ceramic material
• J011264222300: CARMEN® dentin B2, 15 g / dental ceramic material
• J011264214600: CARMEN® dentin A3.5 / 40 g / dental ceramic material
• J011264144300: CARMEN® opaque dentin D4, 15 g / dental ceramic material
• J011262434600: CARMEN® / CCS powder opaque C4, 40 g / dental ceramic material
• J011263170300: CARMEN® shoulder material orange, 15 g / dental ceramic material
• J011264213600: CARMEN® dentin A3, 40 g / dental ceramic material
• J011265160300: CARMEN® incisal transparent 59, 15 g / dental ceramic material
• J011264233300: CARMEN® dentin C3, 15 g / dental ceramic material
• J011264232600: CARMEN® dentin C2, 40 g / dental ceramic material
• J011264213300: CARMEN® dentin A3, 15 g / dental ceramic material
• J011264233600: CARMEN® dentin C3, 40 g / dental ceramic material
• J011266463300: CARMEN® Arteline honey yellow, 15 g / dental ceramic material
• J011264113300: CARMEN® opaque dentin A3, 15 g / dental ceramic material
• J011265370300: CARMEN® incisal opalescent 60, 15 g / dental ceramic material
• J011265360300: CARMEN® incisal opalescent 59, 15 g / dental ceramic material
• J011264242300: CARMEN® dentin D2, 15 g / dental ceramic material
• J011264231300: CARMEN® dentin C1, 15 g / dental ceramic material
• J011264132600: CARMEN® opaque dentin C2, 40 g / dental ceramic material
• J011264132300: CARMEN® opaque dentin C2, 15 g / dental ceramic material
• J011266494300: CARMEN® Arteline olive, 15 g / dental ceramic material