Carmen®

GUDID J011268120300

CARMEN® gingival material dark, 15 g / dental ceramic material

DENTAURUM GmbH & Co.KG

Dental appliance fabrication material, ceramic

• Primary Device ID: J011268120300
• NIH Device Record Key: 6aa9a969-858c-44da-8dcb-4e6366e6d6f4
• Commercial Distribution Discontinuation: 2023-12-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Carmen®
• Version Model Number: 268-120-30
• 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	J011268120300 [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: 2023-12-14
• 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