dima Print Teeth & Temp 66087426

GUDID J014660874260

dima Print Teeth & Temp A3/A3.5 1000g

Kulzer GmbH

Dental acrylic resin

• Primary Device ID: J014660874260
• NIH Device Record Key: 3d0192cd-c01e-4e3a-b393-6f81c805ba36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: dima Print Teeth & Temp
• Version Model Number: 66087426
• Catalog Number: 66087426
• 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: true
• 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(574)291-0661
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J014660874260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233868

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: 2025-02-05
• Device Publish Date: 2025-01-28

On-Brand Devices [dima Print Teeth & Temp]

• J014660874300: dima Print Teeth & Temp A1/B1 1000g
• J014660874280: dima Print Teeth & Temp BL 1000g
• J014660874260: dima Print Teeth & Temp A3/A3.5 1000g
• J014660874240: dima Print Teeth & Temp A2/B2 1000g