RN Synocta UCLA Gold Abutment For The Straumann Dental Implant 010.1075

GUDID 07630031702074

Screw for RN and WN 048.356

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031702074
• NIH Device Record Key: 5e75e86b-e126-4a0c-8c8a-c46364c35f36
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RN Synocta UCLA Gold Abutment For The Straumann Dental Implant
• Version Model Number: Screws
• Catalog Number: 010.1075
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	07630031702074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041295

FDA Product Code

• NHA: Abutment, implant, dental, endosseous

Sterilization

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

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

[07630031702074]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-22
• Device Publish Date: 2022-04-14

Devices Manufactured by Institut Straumann AG

• 07630031776334 - NA: 2025-08-14 Straumann iGuide Template Fixation Pin, Ø 1.5mm, TAN
• 07630031779632 - NA: 2025-08-14 Straumann iGuide T-Sleeve for Template Fixation Pin, Ø 1.5mm, stainless steel
• 07630031776358 - NA: 2025-08-14 Straumann iGuide Drill for Template Fixation Pin, Ø 1.5mm, stainless steel
• 07630031779649 - NA: 2025-08-14 Straumann iGuide T-sleeve, Ø 5.2mm, stainless steel
• 07630031776372 - NA: 2025-08-14 Straumann iGuide Mucosa Punch, for T-sleeve Ø 5.2mm, stainless steel
• 07630031776389 - NA: 2025-08-14 Straumann iGuide Milling Cutter Ø 5mm, for T-sleeve Ø 5.2mm, stainless steel
• 07630031776396 - NA: 2025-08-14 Straumann iGuide Drill Ø 2.2mm, L 6mm, for T-sleeve Ø 5.2mm, stainless steel
• 07630031776402 - NA: 2025-08-14 Straumann iGuide Drill Ø 2.2mm, L 8mm, for T-sleeve Ø 5.2mm, stainless steel