OSTEOTOMES KIT

Basic Information

• Brand Name: OSTEOTOMES KIT
• Primary DI: 07290113356023
• Version / Model: SMB-T001
• Company Name: DENTIN IMPLANTS TECHNOLOGIES LTD
• Labeler DUNS: 600215680
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-10
• Public Version: 1
• Public Version Date: 2018-10-11
• Public Version Status: New
• Public Device Record Key: 2d32e3bc-a186-4845-9858-bd54147adfc7

Device Description

Straight Osteotomes kit

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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
44886	Dental osteotome set	A collection of dental surgical osteotomes used during dental osteotomy for shaping and condensing bone, typically when performing a dental implant surgical procedure. This device typically contains osteotomes of varying sizes and shapes and a surgical mallet or hammer. These are used for ridge expanding, bone condensing and sinus floor elevation procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290113356023	GS1