Scott's Select Temporary Cement NE Jars

Basic Information

• Brand Name: Scott's Select Temporary Cement NE Jars
• Primary DI: 00817441023532
• Version / Model: 199-1009
• Company Name: PRIME DENTAL
• Labeler DUNS: 027480775
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-26
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0350ff34-3e4a-499e-9242-3618dfb62090

Device Description

Scott's Select Temporary Cement NE Jars

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
62234	Home-use dental cement	A non-sterile substance intended to be used as a dental cement/restorative material by a layperson in the home for immediate and temporary replacement of a lost filling or cementation of a dental crown, and to relieve pain, until a dental professional is accessed. It may be either a multicomponent material intended to be pre-mixed before application or a single-component paste; it is intended to be applied directly to the tooth and harden in situ. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817441023532	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 38 – 76 Degrees Fahrenheit