NA

Basic Information

• Brand Name: NA
• Primary DI: 06009544019299
• Version / Model: PPC-MAX9
• Company Name: SOUTHERN IMPLANTS (PTY) LTD
• Labeler DUNS: 636239584
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-05
• Public Version: 2
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: aea815b5-e121-4668-98a8-ff9d22a0f478

Device Description

Polishing Cap for Max9 Ex Hex

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63664	Dental implant suprastructure reamer guide	A manually-operated dental laboratory instrument intended to help guide a manual reamer during smoothing and refining of the surface of the screw channel, screw seat and implant/abutment connection of a dental implant suprastructure, to remove minor casting flashes during the production of a final suprastructure; it is not intended for intraoral use. Also referred to as a reamer gauge, it is in the form of a support with a flat base and slots for mounting the suprastructure and inserting the reamer. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06009544019299	GS1