Enamelast

Basic Information

• Brand Name: Enamelast
• Primary DI: 00883205103178
• Version / Model: 4523
• Catalog Number: 4523
• Company Name: ULTRADENT PRODUCTS, INC.
• Labeler DUNS: 013369913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 5
• Public Version Date: 2022-08-16
• Public Version Status: Update
• Public Device Record Key: 31ae8a0b-cb46-4199-b4bb-0aa2513b3502

Device Description

Enamelast Syringe 20pk - Walterberry

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
LBH	VARNISH, CAVITY	Dental	872.3260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65794	Collagen antibody IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of antibodies to collagen in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00883205103178	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius