BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Fortify

DI: D757G9301F1 · Model: G-9301F · BISCO INC.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Fortify
Primary DI: D757G9301F1
Version / Model: G-9301F
Catalog Number: G-9301F
Company Name: BISCO INC.
Labeler DUNS: 053529939
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2017-06-12
Public Version: 6
Public Version Date: 2022-10-12
Public Version Status: Update
Public Device Record Key: 044c0463-8847-4be6-a47e-71e50a6d8330
Distribution End Date: 2022-10-11

Device Description

Fortify Surface Sealant 5ml Bottle Pkg

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBF	MATERIAL, TOOTH SHADE, RESIN	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34771	Dental unfilled resin sealant/coating	A non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D757G9301F1	HIBCC

Customer Contacts

Phone: +1(847)534-6000
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K882915	000

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 20 – 25 Degrees Celsius