Dima 66081678

GUDID J01466081678

dima Print Denture Teeth - B1

Kulzer GmbH

Resin artificial teeth

• Primary Device ID: J01466081678
• NIH Device Record Key: 8a40b4a1-cd70-48cc-94d2-d36228e5071b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dima
• Version Model Number: 66081678
• Catalog Number: 66081678
• Company DUNS: 315666321
• Company Name: Kulzer GmbH
• Device Count: 1
• DM Exempt: true
• 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: false
• 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)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx
• Phone: +1(800)431-1785
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J01466081678 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172398

FDA Product Code

• PZY: Additively manufactured, preformed, resin denture tooth

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: 2024-11-07
• Device Publish Date: 2024-10-30

On-Brand Devices [Dima]

• J014660874230: dima Print C&B Temp-BL1
• J014660816740: dima Print Denture Teeth-A1
• J01466077059: dima Print Denture Teeth - B2
• J01466077058: dima Print Denture Teeth- B1
• J01466077057: dima Print Denture Teeth - A3.5
• J01466077056: dima Print Denture Teeth - A3
• J01466077055: dima Print Denture Teeth - A2
• J01466077054: dima Print Denture Teeth - A1
• J01466077051: dima Print Denture - Light Pink
• J01466077050: dima Print Denture - Light Reddish Pink
• J0146607705: dima Print Denture - Original Pink
• J01466075560: Denture Base Try-in, Pink
• J01466075558: Denture Base Try-in, White
• J01466087415: dima Print Denture Teeth - BL1
• J01466081678: dima Print Denture Teeth - B1
• J01466081673: dima Print Denture - Dark Pink
• J01466081670: dima Print Denture - Light Reddish Pink