SELECT TEMPORARY FILLING MATERIAL 30 GM JAR

Basic Information

• Brand Name: SELECT TEMPORARY FILLING MATERIAL 30 GM JAR
• Primary DI: D77819910550
• Version / Model: 199-1055
• Catalog Number: 199-1055
• Company Name: SCOTT'S DENTAL SUPPLY L.L.C.
• Labeler DUNS: 137217043
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-04
• Public Version: 4
• Public Version Date: 2018-12-20
• Public Version Status: Update
• Public Device Record Key: 2697c4ed-50bc-487c-b74e-8fa25b4f62a2

Device Description

Scott’s Select Temporary Filling material is indicated for the temporary filling of root canal access opening, cavity preparations that require temporary fillings for short periods during therapeutic treatment and temporary filling for small inlay preparations. Scotts Select Temporary filling material is a single paste that can be applied by spatula. It sets with a slight expansion to a hard material that can be removed without the use of burs. It is a non-eugenol formulation allowing it to be applied in locations where a resin such as a composite restorative or bonding system will be used in the final restorative technique. Instructions for use and SDS available at https://www.scottsdental.com/temporary-filling-material-scott-s-select.html

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
EMA	Cement, Dental	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16705	Zinc polycarboxylate dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. 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	D77819910550	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Weight	30	Gram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius