Dental impression material (Private Label)

Basic Information

• Brand Name: Dental impression material (Private Label)
• Primary DI: E239D7485N1
• Version / Model: D7485N
• Catalog Number: D7485N
• Company Name: Dreve Dentamid GmbH
• Labeler DUNS: 388000846
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-28
• Public Version: 5
• Public Version Date: 2022-08-11
• Public Version Status: Update
• Public Device Record Key: 09138b7e-cc1b-48d7-8794-070d8a84632d
• Distribution End Date: 2022-08-10

Device Description

No.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
ELW	Material, Impression	Dental	872.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E239D7485N1	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 28 Degrees Celsius