ACTIVA™ BioACTIVE Bulk Flow

GUDID D701VBF1US2

1 x 3mL / 5gm syringe + 10 Automix tips, Universal shade (ShadeFusion)

PULPDENT CORPORATION

Dental composite resin

• Primary Device ID: D701VBF1US2
• NIH Device Record Key: 1bb5a60a-e7b3-429a-ad35-b727fd359718
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTIVA™ BioACTIVE Bulk Flow
• Version Model Number: VBF1US
• Company DUNS: 001006089
• Company Name: PULPDENT CORPORATION
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D701VBF1US2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130223

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: 2024-12-10
• Device Publish Date: 2024-12-02

On-Brand Devices [ACTIVA™ BioACTIVE Bulk Flow]

• D701VBF1US2: 1 x 3mL / 5gm syringe + 10 Automix tips, Universal shade (ShadeFusion)
• D701SVBFUS2: 1 x 1gm syringe + 2 Automix tips, Universal shade (ShadeFusion), sample
• D701VBF2US2: 2 x 3 mL / 5 gm syringes + 20 Automix tips, Universal Shade