TAUB - Trident - ECS (Expandable Crown Splitter)

Basic Information

• Brand Name: TAUB - Trident - ECS (Expandable Crown Splitter)
• Primary DI: D8379911500
• Version / Model: 1 mm
• Catalog Number: 99-1150
• Company Name: Taub Products
• Labeler DUNS: 067488114
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-25
• Public Version: 2
• Public Version Date: 2022-06-17
• Public Version Status: Update
• Public Device Record Key: e7026eb7-4140-43c7-86fa-9ca32ebb27d2

Device Description

ECS is a hand held and operated crown splitter. A vertical cut is made into the crown by a cutting wheel and the crown splitter is inserted into the cut. The splitter is squeezed and the unit tip separates and splits the crown open.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Sound Waves", "Moist Heat or Steam Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIS	Remover, Crown	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64422	Dental prosthesis removal instrument	A non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D8379911500	HIBCC

Customer Contacts

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