PROVATA®

GUDID 06009544040927

PROVATA® MSc Implant, Ø6.0 x 15mm

SOUTHERN IMPLANTS (PTY) LTD

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece

• Primary Device ID: 06009544040927
• NIH Device Record Key: d3392c63-0bcb-4a47-8e6f-4d4f0007794c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROVATA®
• Version Model Number: MSC-PRO615
• Company DUNS: 636239584
• Company Name: SOUTHERN IMPLANTS (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06009544040927 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180465

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-29
• Device Publish Date: 2022-07-21

On-Brand Devices [PROVATA®]

• 06009544040934: PROVATA® MSc Implant, Ø6.0 x 18mm
• 06009544040927: PROVATA® MSc Implant, Ø6.0 x 15mm
• 06009544040910: PROVATA® MSc Implant, Ø6.0 x 13mm
• 06009544040903: PROVATA® MSc Implant, Ø6.0 x 11mm
• 06009544040880: PROVATA® MSc Implant, Ø6.0 x 8mm
• 06009544040897: PROVATA® MSc Implant, Ø6.0 x 10mm