Primodent PRI.01B2

GUDID EPOLPRI01B20

PRI01B2

POLIDENT d.o.o.

Resin artificial teeth

• Primary Device ID: EPOLPRI01B20
• NIH Device Record Key: effae412-0dcd-4434-bcff-b0f9c71c6a07
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primodent
• Version Model Number: PRI.01B2
• Catalog Number: PRI.01B2
• Company DUNS: 644778409
• Company Name: POLIDENT d.o.o.
• 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: +38653304840
• Email: polident@polident.si
• Phone: +38653304840
• Email: polident@polident.si
• Phone: +38653304840
• Email: polident@polident.si
• Phone: +38653304840
• Email: polident@polident.si
• Phone: +38653304840
• Email: polident@polident.si

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EPOLPRI01B20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926070

FDA Product Code

• ELM: Denture, Plastic, Teeth

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: 2024-12-17
• Device Publish Date: 2024-12-09

On-Brand Devices [Primodent]

• EPOLPRV01A203: Resin Artificial Teeth
• EPOLPRI01B203: Resin Artificial Teeth
• EPOLPRIT6ZY603: Resin Artificial Teeth
• EPOLPRIT6ZY503: Resin Artificial Teeth
• EPOLPRIT6ZY403: Resin Artificial Teeth
• EPOLPRIT6ZY303: Resin Artificial Teeth
• EPOLPRIT6ZY203: Resin Artificial Teeth
• EPOLPRIT6ZY103: Resin Artificial Teeth
• EPOLPRIT6ZY003: Resin Artificial Teeth
• EPOLPRIT6ZG603: Resin Artificial Teeth
• EPOLPRIT6ZG503: Resin Artificial Teeth
• EPOLPRIT6ZG403: Resin Artificial Teeth
• EPOLPRIT6ZG303: Resin Artificial Teeth
• EPOLPRIT6ZG203: Resin Artificial Teeth
• EPOLPRIT6ZG103: Resin Artificial Teeth
• EPOLPRIT6ZB603: Resin Artificial Teeth
• EPOLPRIT6ZB503: Resin Artificial Teeth
• EPOLPRIT6ZB403: Resin Artificial Teeth
• EPOLPRIT6ZB303: Resin Artificial Teeth
• EPOLPRIT6ZB203: Resin Artificial Teeth
• EPOLPRIT6ZB103: Resin Artificial Teeth
• EPOLPRIT6SY603: Resin Artificial Teeth
• EPOLPRIT6SY503: Resin Artificial Teeth
• EPOLPRIT6SY403: Resin Artificial Teeth
• EPOLPRIT6SY303: Resin Artificial Teeth
• EPOLPRIT6SY203: Resin Artificial Teeth
• EPOLPRIT6SY103: Resin Artificial Teeth
• EPOLPRIT6SY003: Resin Artificial Teeth
• EPOLPRIT6SG603: Resin Artificial Teeth
• EPOLPRIT6SG503: Resin Artificial Teeth
• EPOLPRIT6SG403: Resin Artificial Teeth
• EPOLPRIT6SG303: Resin Artificial Teeth
• EPOLPRIT6SG203: Resin Artificial Teeth
• EPOLPRIT6SG103: Resin Artificial Teeth
• EPOLPRIT6SB603: Resin Artificial Teeth
• EPOLPRIT6SB503: Resin Artificial Teeth
• EPOLPRIT6SB403: Resin Artificial Teeth
• EPOLPRIT6SB303: Resin Artificial Teeth
• EPOLPRIT6SB203: Resin Artificial Teeth
• EPOLPRIT6SB103: Resin Artificial Teeth
• EPOLPRIT4ZY603: Resin Artificial Teeth
• EPOLPRIT4ZY503: Resin Artificial Teeth
• EPOLPRIT4ZY403: Resin Artificial Teeth
• EPOLPRIT4ZY303: Resin Artificial Teeth
• EPOLPRIT4ZY203: Resin Artificial Teeth
• EPOLPRIT4ZY103: Resin Artificial Teeth
• EPOLPRIT4ZY003: Resin Artificial Teeth
• EPOLPRIT4ZG603: Resin Artificial Teeth
• EPOLPRIT4ZG503: Resin Artificial Teeth
• EPOLPRIT4ZG403: Resin Artificial Teeth