Pionext

GUDID 06975471800128

Surgical Guide Resin

Shenzhen Piocreat 3D Technology Co., Ltd

Dental appliance fabrication material, resin

• Primary Device ID: 06975471800128
• NIH Device Record Key: cc3fa149-9a50-432b-84a1-6005a7cde5ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pionext
• Version Model Number: PN-SG
• Company DUNS: 417463219
• Company Name: Shenzhen Piocreat 3D Technology Co., Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06975471800128 [Primary]

FDA Product Code

• EBH: Material, Impression Tray, 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: 2025-01-03
• Device Publish Date: 2024-12-26

On-Brand Devices [Pionext]

• 06975471800142: Gingiva Resin
• 06975471800135: Dental Casting Resin
• 06975471800128: Surgical Guide Resin
• 06975471800111: Customized Impression Tray Resin
• 06975471800104: Water Washable Model Resin
• 06975471800098: Removable Die Model Resin
• 06975471800081: Ortho Model Resin 2.0
• 06975471800074: Ortho Model Resin
• 06975471800067: Splint Flex Resin
• 06975471800050: Splint Resin
• 06975471800043: Try-in Resin
• 06975471800036: Indirect Bonding Tray Resin
• 06975471800029: Denture Base Resin
• 06975471800012: Denture Base Resin