SYNOCTA ABUTMENTS 048.601

GUDID 07630031725196

RN synOcta® 1.5 screw-retained Abutment, H 1.5mm, TAN

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031725196
• NIH Device Record Key: 3d7dfe17-fedb-49be-9d92-e6c680b7f7ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNOCTA ABUTMENTS
• Version Model Number: Final Abutments
• Catalog Number: 048.601
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: false
• 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

Device Dimensions

• Angle: 15 degree
• Angle: 15 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031725196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073628

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031725196]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-09-24

Devices Manufactured by Institut Straumann AG

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• 07630031703064 - Base metal alloy: 2025-06-16 ticon Titanium primary crown
• 07630031742261 - Straumann TLX Implant System: 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 6mm, Roxolid®
• 07630031742292 - Straumann TLX Implant System: 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 12mm, Roxolid®
• 07630031742308 - Straumann TLX Implant System: 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 14mm, Roxolid®
• 07630031742315 - Straumann TLX Implant System: 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 16mm, Roxolid®
• 07630031742322 - Straumann TLX Implant System: 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 18mm, Roxolid®