Concave Tip Offset Osteotome Kit

Basic Information

• Brand Name: Concave Tip Offset Osteotome Kit
• Primary DI: D785OSTOSCKIT0
• Version / Model: Concave Tip Offset Osteotome Kit (3)
• Catalog Number: OST-OS-C Kit
• Company Name: OCO BIOMEDICAL INC
• Labeler DUNS: 094146123
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-29
• Public Version: 3
• Public Version Date: 2024-02-23
• Public Version Status: Update
• Public Device Record Key: 44913c50-34ac-4fcb-8edb-db698a6673c7

Device Description

Concave Tip Offset Osteotome Kit (3) All 3 with case 2.65mm Concave Tip Offset Osteotome 3.4mm Concave Tip Offset Osteotome 4.4mm Concave Tip Offset Osteotome

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
DZN	Instruments, Dental Hand	Dental	872.4565	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	D785OSTOSCKIT0	HIBCC