3Delta Try-In

Basic Information

• Brand Name: 3Delta Try-In
• Primary DI: EDEL16211100
• Version / Model: 1621110
• Catalog Number: 1621110
• Company Name: DeltaMed GmbH
• Labeler DUNS: 344805101
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-11
• Public Version: 1
• Public Version Date: 2022-02-21
• Public Version Status: New
• Public Device Record Key: 47bf747b-008f-488f-93d8-0ea085bb7a5b

Device Description

3Delta Try-In 500g

Device Characteristics

• Single Use: Yes
• 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
EEA	Plate, Base, Shellac	Dental	872.6200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34808	Dental base plate	A foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EDEL16211100	HIBCC

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: avoid direct sunlight