DenSureFit

GUDID 00863995000109

DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysiloxane, 1 vial primer, 2 stick applicators and 1 IFU. The kit is intended to reline one denture plate. It is intended to provide temporary relief from ill-fitting dentures until a dentist can be seen.

OTC DENTAL CORPORATION

Denture reliner, soft, home-use

• Primary Device ID: 00863995000109
• NIH Device Record Key: 9d894725-2763-41d0-81e4-8ccbce6758e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DenSureFit
• Version Model Number: DSF212.00
• Company DUNS: 080416887
• Company Name: OTC DENTAL CORPORATION
• 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: 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863995000109 [Primary]

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing
• EBP: Reliner, Denture, Over The Counter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-09
• Device Publish Date: 2017-01-23

On-Brand Devices [DenSureFit]

• 00863995000109: DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysil
• 00863995000123: DenSureFit is an over-the-counter soft reline kit. It consists of 2 applicators of vinyl polysil