PUR® NP Cover Screw .050 Hex 3.5mm

Basic Information

• Brand Name: PUR® NP Cover Screw .050 Hex 3.5mm
• Primary DI: 00841549107900
• Version / Model: 901442
• Company Name: STERNGOLD DENTAL LLC
• Labeler DUNS: 124763728
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-29
• Public Version: 1
• Public Version Date: 2020-06-08
• Public Version Status: New
• Public Device Record Key: aa7d5767-8e67-4489-a53d-a8208099a7ac

Device Description

Component that is attached to implant to protect hex, mating surface area and internal threads of implants. A cover screw closes off the inside threads of a dental implant during the period of bone healing and implant integration. Healed gingival tissue covers the cover screw and implant. Available as an Internal Hex Cover Screw and on Regular and Narrow Platforms.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
DZE	Implant, Endosseous, Root-Form	Dental	872.3640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44879	Dental implant suprastructure, permanent, preformed	A prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841549107900	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151928	000