XiVE®

GUDID 07392532212079

Single-Patient-Drill D3.0/L8-15

Dentsply Implants Manufacturing GmbH

Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use Fixture/appliance dental drill bit, single-use

• Primary Device ID: 07392532212079
• NIH Device Record Key: 573994eb-8e43-47c0-9489-904d02cbb196
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XiVE®
• Version Model Number: 26-1025
• Company DUNS: 344038836
• Company Name: Dentsply Implants Manufacturing GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	07392532212079 [Primary]

FDA Product Code

• NDP: Accessories, implant, dental, endosseous

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: 2023-12-29
• Device Publish Date: 2023-12-21

On-Brand Devices [XiVE®]

• EFRI324643012: MP Screw long
• EFRI324632602: MP Retention Sleeve long D5.5
• EFRI324632502: MP Retention Sleeve long D4.5
• EFRI324632402: MP Retention Sleeve long D3.8
• EFRI324632302: MP Retention Sleeve long D3.4
• EFRI324631602: MP Retention Sleeve short D5.5
• EFRI324631502: MP Retention Sleeve short D4.5
• EFRI324631402: MP Retention Sleeve short D3.8
• EFRI324631302: MP Retention Sleeve short D3.4
• EFRI324631002: MP Insert Head
• EFRI324630432: MP Abutment D3.8-5.5/GH3/A30
• EFRI324630422: MP Abutment D3.8-5.5/GH2/A30
• EFRI324630332: MP Abutment D3.4/GH3/A30
• EFRI324630322: MP Abutment D3.4/GH2/A30
• EFRI324629452: MP Abutment D3.8-5.5/GH5/A15
• EFRI324629432: MP Abutment D3.8-5.5/GH3/A15
• EFRI324629422: MP Abutment D3.8-5.5/GH2/A15
• EFRI324629352: MP Abutment D3.4/GH5/A15
• EFRI324629332: MP Abutment D3.4/GH3/A15
• EFRI324629322: MP Abutment D3.4/GH2/A15
• EFRI322641062: Conometric Abutment Ø3.8/3.0/15°/Ø4.5/I
• EFRI322641052: Conometric Abutment Ø3.8/2.0/15°/Ø4.5/I
• EFRI322641042: Conometric Abutment Ø3.8/1.0/15°/Ø4.5/I
• EFRI322641032: Conometric Abutment Ø3.8/3.0/0°/Ø4.5/I
• EFRI322641022: Conometric Abutment Ø3.8/2.0/0°/Ø4.5/I
• EFRI322641012: Conometric Abutment Ø3.8/1.0/0°/Ø4.5/I
• EFRI322640062: Conometric Abutment Ø3.4/3.0/15°/Ø4.5/I
• EFRI322640052: Conometric Abutment Ø3.4/2.0/15°/Ø4.5/I
• EFRI322640042: Conometric Abutment Ø3.4/1.0/15°/Ø4.5/I
• EFRI322640032: Conometric Abutment Ø3.4/3.0/0°/Ø4.5/I
• EFRI322640022: Conometric Abutment Ø3.4/2.0/0°/Ø4.5/I
• EFRI322640012: Conometric Abutment Ø3.4/1.0/0°/Ø4.5/I
• EFRI322545202: XiVE® TG AuroBase D3.4-4.5
• EFRI322545102: XiVE® TG Abutment angled D3.4-4.5/A15
• EFRI322545002: XiVE® TG Abutment straight D3.4-4.5/A0
• EFRI322543002: XiVE® TG Abutment Screw
• EFRI322542462: XiVE® TG Cast-to Waxing Sleeve D3.4-4.5
• EFRI322542412: XiVE® TG Titanium Bar Coping with Guide Pin
• EFRI322542402: XiVE® TG Gold Bar Coping with Guide Pin
• EFRI322542002: XiVE® TG Coping Screw
• EFRI322624652: XiVE® S plus Implant D5.5/L15
• EFRI322624632: XiVE® S plus Implant D5.5/L13
• EFRI322624622: XiVE® S plus Implant D5.5/L11
• EFRI322624612: XiVE® S plus Implant D5.5/L9.5
• EFRI322624602: XiVE® S plus Implant D5.5/L8
• EFRI322624582: XiVE® S plus Implant D4.5/L18
• EFRI322624552: XiVE® S plus Implant D4.5/L15
• EFRI322624532: XiVE® S plus Implant D4.5/L13
• EFRI322624522: XiVE® S plus Implant D4.5/L11
• EFRI322624512: XiVE® S plus Implant D4.5/L9.5