Straumann Screw-Retained Abutments

Basic Information

• Brand Name: Straumann Screw-Retained Abutments
• Primary DI: 07630031746030
• Version / Model: Protective caps
• Catalog Number: 024.0020-04
• Company Name: Institut Straumann AG
• Labeler DUNS: 483599259
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2023-08-02
• Public Version: 1
• Public Version Date: 2023-08-10
• Public Version Status: New
• Public Device Record Key: f269e02d-ce7b-4bc8-93df-27daffd97ac6

Device Description

Protective Cap for Screw-retained Abutment, Ø 4.6mm, H 5.1mm, wide, PEEK/TAN

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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
NHA	Abutment, implant, dental, endosseous	Dental	872.3630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44880	Dental implant suprastructure, temporary, preformed, single-use	A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07630031755827	GS1
Primary	07630031746030	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192401	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	4.6	Millimeter
Height	5.1	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight