Pic-N-Stic

GUDID D701PIC2

A handle for small objects

PULPDENT CORPORATION

Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use Dental material application tool, single-use

• Primary Device ID: D701PIC2
• NIH Device Record Key: b23a7cfc-9132-4052-8420-014e6489a40c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pic-N-Stic
• Version Model Number: PIC
• Company DUNS: 001006089
• Company Name: PULPDENT CORPORATION
• Device Count: 60
• 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: true
• 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	D701PIC1 [Unit of Use]
HIBCC	D701PIC2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K911281

FDA Product Code

• EKJ: Burnisher, Operative

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: 2021-09-29
• Device Publish Date: 2021-09-21

Devices Manufactured by PULPDENT CORPORATION

• D701SUNO2 - DENTASTIC UNO SAMPLE: 2024-02-16 Adhesive, dentine, applicator brush
• D701SVPFA32 - Activa Presto: 2023-06-30 .6 mL sample A3 shade + 5 tips
• D701SVPFA352 - Activa Presto: 2023-06-30 .6 mL sample A3.5 shade + 5 tips
• D701SVPFA42 - Activa Presto: 2023-06-30 .6 mL sample A4 shade + 5 tips
• D701SVPFA62 - Activa Presto: 2023-06-30 .6 mL sample A6 shade + 5 tips
• D701SVPFB12 - Activa Presto: 2023-06-30 .6 mL sample B1 shade + 5 tips
• D701TTP502 - Tuff Temp Plus Provisional Veneer, Crown, and Bridge Resin: 2021-10-29 50 mL automix syringe cartridge with ten applicator tips
• D701TTP50A12 - TUFF-TEMP PLUS: 2021-10-29 TUFF-TEMP PLUS A1 SHADE 50 ml cartridge + 10 tips only