GBR Screw

Basic Information

• Brand Name: GBR Screw
• Primary DI: 08806169157232
• Version / Model: DBS1405
• Company Name: DENTIS CO. ,LTD
• Labeler DUNS: 694721181
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-31
• Public Version: 2
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: c06bde99-b7b6-4430-b09f-042c13c8af62

Device Description

GBR Screw / DBS1405

Device Characteristics

• Single Use: Yes
• 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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZL	Screw, Fixation, Intraosseous	Dental	872.4880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46645	Dental regeneration membrane fixation tack, non-bioabsorbable	A non-bioabsorbable tack intended to be driven into bone to fix or stabilize bioabsorbable barrier membranes used for the regeneration of tissue and/or bone in the oral cavity, or used for other clinical situations that require membrane utilization. The device is typically made of metal (e.g., titanium alloy). This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806169157232	GS1

Premarket Submissions

Submission Number	Supplement Number
K222367	000