DenSureFit Pro

GUDID 00860013103255

DenSureFit Pro is for professional use only. DSF Pro is a chairside denture reline kit utilizing Vinyl Polysiloxane as the reline material. The contents of the kit contains (1) IFU,(1) 50cc cartridge of VPS, (10) mixing tips compatible with 50cc cartridge, (10) medical swabs, (1)15mL vial of Primer, (5) Snug Up At-Home Care kits for home use. The contents of each Snug Up At-Home Care Kit contains (1) 5mL cartridge of VPS, (3) mixing tips compatible with 5mL cartridge, & (1) At-Home IFU.

OTC DENTAL CORPORATION

Denture reliner, soft, home-use

• Primary Device ID: 00860013103255
• NIH Device Record Key: 39d266ed-0888-4846-b9c5-0a966e2d8805
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DenSureFit Pro
• Version Model Number: DSFProKit
• Company DUNS: 080416887
• Company Name: OTC DENTAL 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: 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
GS1	00860013103255 [Primary]

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: 2025-09-10
• Device Publish Date: 2025-09-02

Devices Manufactured by OTC DENTAL CORPORATION

• 00860013103255 - DenSureFit Pro: 2025-09-10DenSureFit Pro is for professional use only. DSF Pro is a chairside denture reline kit utilizing Vinyl Polysiloxane as the reline material. The contents of the kit contains (1) IFU,(1) 50cc cartridge of VPS, (10) mixing tips compatible with 50cc cartridge, (10) medical swabs, (1)15mL vial of Primer, (5) Snug Up At-Home Care kits for home use. The contents of each Snug Up At-Home Care Kit contains (1) 5mL cartridge of VPS, (3) mixing tips compatible with 5mL cartridge, & (1) At-Home IFU.
• 00860013103255 - DenSureFit Pro: 2025-09-10 DenSureFit Pro is for professional use only. DSF Pro is a chairside denture reline kit utilizing Vinyl Polysiloxane as the relin
• 00863995000109 - DenSureFit: 2018-08-09 DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick a