TempoLok NE Cement 118g cartridge, 50 mixing tips

Basic Information

• Brand Name: TempoLok NE Cement 118g cartridge, 50 mixing tips
• Primary DI: 00841549100475
• Version / Model: 220282
• Company Name: STERNGOLD DENTAL LLC
• Labeler DUNS: 124763728
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-24
• Public Version: 5
• Public Version Date: 2022-03-04
• Public Version Status: Update
• Public Device Record Key: 3269aff1-f8b4-42e4-a613-0bbcb2877f0a
• Distribution End Date: 2022-03-02

Device Description

The TempoLok™ Automix NE refill includes: one double cartridge (118 g) non-eugenol, zinc oxide cement and 50 mixing tips. This product is used for temporary cement for attaching all kinds of temporaries, e.g. temporary crowns and bridges and inlays. They can also be used as a securely sealing protective cover for preparations to be restored later.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
62200	Zinc oxide eugenol dental cement	A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). 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	00841549100475	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K984340	000