Simple Guide Plus Sleeve Connector

Basic Information

• Brand Name: Simple Guide Plus Sleeve Connector
• Primary DI: 08800053004701
• Version / Model: DSGPSC
• Company Name: DENTIS CO. ,LTD
• Labeler DUNS: 694721181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-01
• Public Version: 1
• Public Version Date: 2021-06-09
• Public Version Status: New
• Public Device Record Key: 55577552-036a-4661-9745-b17997b757cc

Device Description

Dental Implant Instrument / Simple Guide Plus Sleeve Connector

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63963	Dental appliance/prosthesis connector	A small device in the form of a combination sleeve/screw intended to provide a secure connection between two dental suprastructures, or between a dental suprastructure and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture); it may also be used to provide an anchor point for a tool to temporarily remove a prosthesis/restoration, e.g., for cleaning. It is in the form of a sleeve and screw set where the sleeve is fixed in a pre-drilled hole or glued to the outside of the appliance. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800053004701	GS1