FotoDent® tray2

Basic Information

• Brand Name: FotoDent® tray2
• Primary DI: E239D3530011
• Version / Model: D353001
• Catalog Number: D353001
• Company Name: Dreve Dentamid GmbH
• Labeler DUNS: 388000846
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-18
• Public Version: 1
• Public Version Date: 2023-04-26
• Public Version Status: New
• Public Device Record Key: 090e78c1-2664-49fc-9a07-ba86cc9a3a1b

Device Description

No.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
EBH	MATERIAL, IMPRESSION TRAY, RESIN	Dental	872.3670	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58106	Dental impression tray material	A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E239D3530011	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight
• Type: Storage Environment Temperature
• Temperature Range: 18 – 28 Degrees Celsius