Tall Separable Fastener 10-Pack, w/ Cementation Aid, Ditron

Basic Information

• Brand Name: Tall Separable Fastener 10-Pack, w/ Cementation Aid, Ditron
• Primary DI: D990DDUSTSFCA10PK0
• Version / Model: DDUS-TSFCA10PK
• Company Name: Smart Denture Conversions, LLC
• Labeler DUNS: 010613514
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-19
• Public Version: 1
• Public Version Date: 2023-05-29
• Public Version Status: New
• Public Device Record Key: c6200fd4-d00d-4a9f-95be-8d9cff9afde2

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: 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
EJX	Anchor, Preformed	Dental	872.3130	1
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33968	Surgical screwdriver, reusable	A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.	No	Active
64312	Dental prosthesis/implant abutment screw analog, single-use	A device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Some types are referred to as a guide pin, and may be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D990DDUSTSFCA10PK0	HIBCC

Customer Contacts

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