Medental 0PT452

GUDID P07502291840028

P.C.A. Cement kit 25gr. 15ml.

MEDENTAL INTERNATIONAL INC

Zinc polycarboxylate dental cement

• Primary Device ID: P07502291840028
• NIH Device Record Key: cf4c9f2c-8ef9-477b-a677-e16aff98c47f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medental
• Version Model Number: PCCS25g15ml
• Catalog Number: 0PT452
• Company DUNS: 082167227
• Company Name: MEDENTAL INTERNATIONAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	P07502291840028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980990

FDA Product Code

• EMA: Cement, Dental

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: 2023-09-18
• Device Publish Date: 2023-09-08