Activa Presto

GUDID D701SVPFA62

.6 mL sample A6 shade + 5 tips

PULPDENT CORPORATION

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: D701SVPFA62
• NIH Device Record Key: 46c15ef5-c092-4857-b45b-1c4fb3c82234
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Activa Presto
• Version Model Number: S-VPFA6
• 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	D701SVPFA62 [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