Tatum Surgical-Tapered Osteotome Kit

Basic Information

• Brand Name: Tatum Surgical-Tapered Osteotome Kit
• Primary DI: 00083208044441
• Version / Model: Tatum Tapered Offset Osteotome Kit
• Catalog Number: OsteotomeTapered Offset 24
• Company Name: Suncoast Dental, Inc
• Labeler DUNS: 078352849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-04
• Public Version: 1
• Public Version Date: 2020-08-12
• Public Version Status: New
• Public Device Record Key: 4d223988-4d96-40c9-9045-7fc59af19331

Device Description

Tatum Tapered Offset Osteotome Kit designed for use in bone expansion utilizing Tatum Tapered & Integrity Implants: Includes 24 instruments and 2 Autoclaveable cassettes: White - 3.0x15, 18, 21, 23, Blue - 3.5x12, 15, 18, & 21 Red - 4.0x12, 15, 18, & 21 Yellow - 4.5x12, 15, 18, & 21 Black - 5.0x12, 15, 18, & 21 Green - 6.0x12, 15, 18, & 21

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: No
• 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
EMM	Chisel, Osteotome, Surgical	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	00083208044441	GS1

Customer Contacts

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