Flexible Partial Resin 70-1164-RSN0008

GUDID D745701164RSN00080

Flexible Partial Resin Shade G1

Prismatik Dentalcraft, Inc

Dental appliance fabrication material, resin

• Primary Device ID: D745701164RSN00080
• NIH Device Record Key: 2d50fe8c-2ea0-44a6-85e2-bb1131490835
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexible Partial Resin
• Version Model Number: 70-1164-RSN0008
• Catalog Number: 70-1164-RSN0008
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, Inc
• 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: true
• 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	D745701164RSN00080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250302

FDA Product Code

• EBI: RESIN, DENTURE, RELINING, REPAIRING, REBASING

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: 2025-08-27
• Device Publish Date: 2025-08-19

On-Brand Devices [Flexible Partial Resin]

• D745701164RSN00100: Flexible Partial Resin Shade G4
• D745701164RSN00090: Flexible Partial Resin Shade G3
• D745701164RSN00080: Flexible Partial Resin Shade G1