TACK-3-PT

Basic Information

• Brand Name: TACK-3-PT
• Primary DI: 00841336100015
• Version / Model: Rev3
• Company Name: Salvin Dental Specialties, Inc.
• Labeler DUNS: 113344790
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: dd84bbb8-04e3-4ce6-bd24-61b716ce0b1f

Device Description

SALVIN POWER TIP TITANIUM BONE TACK-3MM (PKG OF 5)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
DZL	Screw, Fixation, Intraosseous	Dental	872.4880	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46640	Craniofacial bone tack, non-bioabsorbable	A small, sterile, cylindrical shaft typically with a flat, rounded head at one end and tapered to a point at the other, that is driven into craniofacial bone (includes maxilla and/or mandible) to provide stabilization for fracture repair and reconstructive procedures; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., titanium alloy). The device may be used when rigid fixation with bone plates and screws is not required.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841336100015	GS1

Premarket Submissions

Submission Number	Supplement Number
K100182	000