Institut Straumann AG 010.6077

GUDID 07630031736338

RC Variobase® for Crown, incl. screw, D 4.5mm, AH 5.5mm, GH 3mm, TAN

Institut Straumann AG

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031736338
• NIH Device Record Key: 12524fb4-6576-4086-9062-5115fb663e76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Institut Straumann AG
• Version Model Number: Final Abutments
• Catalog Number: 010.6077
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• 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

Customer Support Contacts

• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com

Device Dimensions

• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 4.5 Millimeter
• Height: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031736338 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142890

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

[07630031736338]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-07-19

Devices Manufactured by Institut Straumann AG

• 07630031775580 - Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs: 2024-04-25 n!ce ZirconiaHT, Multi BL3, 14mm
• 07630031775597 - Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs: 2024-04-25 n!ce ZirconiaHT, Multi BL3, 16mm
• 07630031775603 - Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs: 2024-04-25 n!ce ZirconiaHT, Multi BL3, 20mm
• 07630031775610 - Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs: 2024-04-25 n!ce ZirconiaHT, Multi BL3, 25mm
• 07630031775627 - Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs: 2024-04-25 n!ce ZirconiaHT, Multi BL3, 30mm
• 07630031771452 - Straumann Variobase C: 2024-04-11 RB/WB Variobase C, incl. screw, Ø 4.5mm, GH 2.5mm, TAN
• 07630031771469 - Straumann Variobase C: 2024-04-11 RB/WB Variobase C, incl. screw, Ø 4.5mm, GH 3.5mm, TAN
• 07630031771476 - Straumann Variobase C: 2024-04-11 WB Variobase C, incl. screw, Ø 5.5mm, GH 0.75mm, TAN