Activa Presto

GUDID D701SVPFB12

.6 mL sample B1 shade + 5 tips

PULPDENT CORPORATION

Dental composite resin

• Primary Device ID: D701SVPFB12
• NIH Device Record Key: 33c5332b-c0db-4f2a-b367-6bfc830a33ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Activa Presto
• Version Model Number: S-VPFB1
• 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	D701SVPFB12 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153249

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2023-06-30
• Device Publish Date: 2023-06-22

On-Brand Devices [Activa Presto]

• D701VPF1BW2: 2 x 1.2 mL syringe + 20 tips, shade bleach white
• D701VPF1B12: 2 x 1.2 mL syringe + 20 tips, shade B1
• D701VPF1A62: 2 x 1.2 mL syringe + 20 tips, shade A6
• D701VPF1A42: 2 x 1.2 mL syringe + 20 tips, shade A4
• D701VPF1A352: 2 x 1.2 mL syringe + 20 tips, shade A3.5
• D701VPF1A32: 2 x 1.2 mL syringe + 20 tips, shade A3
• D701VPF1A22: 2 x 1.2 mL syringe + 20 tips, shade A2
• D701VPF1A12: 2 x 1.2 mL syringe + 20 tips, shade A1
• D701SVPFBW2: .6 mL sample bleach white shade + 5 tips
• D701SVPFA22: .6 mL sample A2 shade + 5 tips
• D701SVPFA12: .6 mL sample A1 shade + 5 tips
• D701SVPFB12: .6 mL sample B1 shade + 5 tips
• D701SVPFA62: .6 mL sample A6 shade + 5 tips
• D701SVPFA42: .6 mL sample A4 shade + 5 tips
• D701SVPFA352: .6 mL sample A3.5 shade + 5 tips
• D701SVPFA32: .6 mL sample A3 shade + 5 tips