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

• 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

• 07630031754530 - Straumann BLX Line Extension - New Abutments: 2024-09-12 RB/WB Temporary Abutment, Bridge, Ø 4.5mm, GH 1.5mm, AH 10mm, TAN
• 07630031764522 - Straumann® BLC and TLC Implants: 2024-08-12 BLC Implant, Ø 5.5mm WB, SLA 14mm, Roxolid
• 07630031764539 - Straumann® BLC and TLC Implants: 2024-08-12 BLC Implant, Ø 5.5mm WB, SLA 16mm, Roxolid
• 07630031764584 - Straumann® BLC and TLC Implants: 2024-08-12 BLC Implant, Ø 5.5mm WB, SLActive 14mm, Roxolid
• 07630031764591 - Straumann® BLC and TLC Implants: 2024-08-12 BLC Implant, Ø 5.5mm WB, SLActive 16mm, Roxolid
• 07630031764645 - Straumann® BLC and TLC Implants: 2024-08-12 BLC Implant, Ø 6.5mm WB, SLA 14mm, Roxolid
• 07630031764706 - Straumann® BLC and TLC Implants: 2024-08-12 BLC Implant, Ø 6.5mm WB, SLActive 14mm, Roxolid
• 07630031772534 - NA: 2024-06-13 TLX SP Guided Implant Driver, for adapter, H4 stop, stainless steel