Burkhart Dental Supply

Basic Information

• Brand Name: Burkhart Dental Supply
• Primary DI: 00810052619996
• Version / Model: 72721964
• Company Name: BURKHART DENTAL SUPPLY CO., THE
• Labeler DUNS: 027532357
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-26
• Public Version: 1
• Public Version Date: 2024-02-05
• Public Version Status: New
• Public Device Record Key: f5ab21df-0f81-4e4a-94a2-d0886ed01190

Device Description

1:1 Temp Crown & Bridge Material A1 50ml

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: 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
EBG	Crown And Bridge, Temporary, Resin	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810052619996	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 25 Degrees Celsius