HARDCORE®

GUDID D701HC2

CORE BUILD-UP MATERIAL - DUAL CURE, FLUORIDE RELEASING KIT: 20 gm base + 20 gm dual catalyst, 20 core forms, mixing pad, spatulas

PULPDENT CORPORATION

Dental composite resin

• Primary Device ID: D701HC2
• NIH Device Record Key: 13def9e3-a3d7-4078-8de4-7318389e796c
• Commercial Distribution Discontinuation: 2019-01-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: HARDCORE®
• Version Model Number: HC
• 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: true
• 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 Dimensions

• Weight: 20 Gram

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D701HC2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922755

FDA Product Code

• EMA: Cement, Dental

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-26
• Device Publish Date: 2016-09-01

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