DDP Osseodensification Bur Kit

Basic Information

• Brand Name: DDP Osseodensification Bur Kit
• Primary DI: 00083208134449
• Version / Model: Osseodensification Bur Kit
• Catalog Number: Osseodensification Bur Kit
• Company Name: Suncoast Dental, Inc
• Labeler DUNS: 078352849
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-09
• Public Version: 2
• Public Version Date: 2022-12-09
• Public Version Status: Update
• Public Device Record Key: 8bcccb03-f99d-4e39-aad0-8d4ef842282c
• Distribution End Date: 2022-12-08

Device Description

Set of 12 burs and 4 socket guides used to prepare osteotomies for dental implant placement in the mandible and maxilla.

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
EJL	Bur, Dental	Dental	872.3240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36249	Orthopaedic bur, reusable	A rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00083208134449	GS1

Customer Contacts

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