ApaCal ART 30001-1

GUDID D96730001A04

PREVEST DENPRO LIMITED

Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement Calcium hydroxide dental cement

• Primary Device ID: D96730001A04
• NIH Device Record Key: a30c4516-f149-4fc8-964c-4452cb9c9b29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ApaCal ART
• Version Model Number: Trial Pack
• Catalog Number: 30001-1
• Company DUNS: 859546940
• Company Name: PREVEST DENPRO LIMITED
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D96730001A04 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212475

FDA Product Code

• EJK: Liner, Cavity, Calcium Hydroxide

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: 2022-12-14
• Device Publish Date: 2022-12-06

On-Brand Devices [ApaCal ART]

• D96730001A04: Trial Pack
• D967300010: Intro Pack