Smart Template2-unit Bridge Small, Short

Basic Information

• Brand Name: Smart Template2-unit Bridge Small, Short
• Primary DI: 08800209372296
• Version / Model: HSGTB63SS
• Company Name: Osstem Implant Co., Ltd.
• Labeler DUNS: 689051793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: 3ddb13d5-c3db-4da1-aa39-62ab09cbec5f

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: Yes
• 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
63484	Dental implantation drilling template, custom-made	A custom-made device intended to be used by a dental surgeon to guide drilling in the jawbone of a patient during the first stage of a guided dental implantation procedure for dental implant or orthodontic mini-implant placement/fixation. It is in the form of a shaped plate with a predefined hole(s) or a thermoformed mouldable cylinder and is capable of being used on fully and partially edentulous patients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800209372296	GS1