KONTACT S

GUDID 03701045275367

Implant Øexternal 4.5mm L08mm Øcore 3.6mm

BIOTECH DENTAL

Dental implant system

• Primary Device ID: 03701045275367
• NIH Device Record Key: 106c8c55-4bc1-4910-ba5c-2710f18a74e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KONTACT S
• Version Model Number: K4508-36S
• Company DUNS: 265382983
• Company Name: BIOTECH DENTAL
• 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: false
• 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

Customer Support Contacts

• Phone: 866 277-5662
• Email: info@biotechdentalusa.com
• Phone: 866 277-5662
• Email: info@biotechdentalusa.com
• Phone: 866 277-5662
• Email: info@biotechdentalusa.com
• Phone: 866 277-5662
• Email: info@biotechdentalusa.com
• Phone: 866 277-5662
• Email: info@biotechdentalusa.com
• Phone: 866 277-5662
• Email: info@biotechdentalusa.com
• Phone: 866 277-5662
• Email: info@biotechdentalusa.com
• Phone: 866 277-5662
• Email: info@biotechdentalusa.com
• Phone: 866 277-5662
• Email: info@biotechdentalusa.com
• Phone: 866 277-5662
• Email: info@biotechdentalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701045275367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213997

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: 2022-08-04
• Device Publish Date: 2022-07-27

On-Brand Devices [KONTACT S]

• 03701045271291: Implant Ø4.2mm L14mm
• 03701045271284: Implant Ø4.2mm L12mm
• 03701045271277: Implant Ø4.2mm L10mm
• 03701045271260: Implant Ø4.2mm L08mm
• 03701045230472: Implant Ø5.4mm L14mm
• 03701045230465: Implant Ø5.4mm L12mm
• 03701045230458: Implant Ø5.4mm L10mm
• 03701045230441: Implant Ø5.4mm L08mm
• 03701045230410: Implant Ø4.8mm L14mm
• 03701045230403: Implant Ø4.8mm L12mm
• 03701045230397: Implant Ø4.8mm L10mm
• 03701045230380: Implant Ø4.8mm L08mm
• 03701045230366: Implant Ø4.2mm L16mm
• 03701045230304: Implant Ø3.6mm L16mm
• 03701045230298: Implant Ø3.6mm L14mm
• 03701045230281: Implant Ø3.6mm L12mm
• 03701045230274: Implant Ø3.6mm L10mm
• 03701045230267: Implant Ø3.6mm L08mm
• 03701045275381: Implant Øexternal 4.5mm L12mm Øcore 3.6mm
• 03701045275374: Implant Øexternal 4.5mm L10mm Øcore 3.6mm
• 03701045275367: Implant Øexternal 4.5mm L08mm Øcore 3.6mm
• 03701045273776: External implant 5.5mm L12mm Øcore 4.2mm
• 03701045273769: External implant 5.5mm L10mm Øcore 4.2mm
• 03701045273752: Implant Øexternal 5.5mm L08mm Øcore 4.2mm
• 03701045273745: Implant Øexternal 5.0mm L12mm Øbody 4.2mm
• 03701045273738: Implant Øexternal 5.0mm L10mm Øcore 4.2mm
• 03701045273721: Implant Øexternal 5.0mm L08mm Øcore 4.2mm
• 03701045273714: Implant Øexternal 4.5mm L12mm Øcore 4.2mm
• 03701045273707: Implant Øexternal 4.5mm L10mm Øcore 4.2mm
• 03701045273691: Implant Øexternal 4.5mm L08mm Øcore 4.2mm
• 03701045273684: Implant Øexternal 4.0mm L12mm Øcore 3.6mm
• 03701045273677: Implant Øexternal 4.0mm L10mm Øcore 3.6mm
• 03701045273660: Implant Øexternal 4.0mm L08mm Øcore 3.6mm
• 03701045236795: Angulated conical abutment 30° H4mm +KVP screw
• 03701045234364: Angulated conical abutment 30° H3mm +KVP screw
• 03701045234340: Angulated conical abutment 30° H2mm +KVP screw
• 03701045233558: Angulated narrow conical abutment 30° H4mm +KVP screw
• 03701045271703: Ti-Base pour pilier conique étroit + visKECEEAVGCNV
• 03701045270218: Ti-Base for narrow conical abutment H2mm +KECEEAVGCNV screw
• 03701045270201: Ti-Base for conical abutment H2mm + EAVGC screw
• 03701045237426: Ti-Base base Ø4.0mm H0.7mm +KVP screw
• 03701045236818: Angulated non indexed conical abutment 30° H4mm +KVP screw
• 03701045234500: Titane base for conical abutment + EAVGC screw
• 03701045234395: Angulated non indexed conical abutment 30° H5mm +KVP screw
• 03701045234388: Angulated conical abutment 30° H5mm +KVP screw
• 03701045234371: Angulated non indexed conical abutment 30° H3mm +KVP screw
• 03701045234357: Angulated non indexed conical abutment 30° H2mm +KVP screw
• 03701045237648: Ti-Base base Ø5.0mm H5mm +KVP screw
• 03701045237624: Ti-Base base Ø5.0mm H4mm +KVP screw
• 03701045237600: Ti-Base base Ø5.0mm H3mm +KVP screw