SYNOCTA PROSTHETICS 010.6119

GUDID 07630031739254

RN synOcta® Cementable Abutment, for crowns/bridges, H 5.5mm, Ti

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031739254
• NIH Device Record Key: d4a044c7-a591-4b0e-9ce5-413874f3b0ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYNOCTA PROSTHETICS
• Version Model Number: Final Abutments
• Catalog Number: 010.6119
• 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: 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: +1(801)448-8168
• Email: info.usa@straumann.com

Device Dimensions

• Height: 5.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031739254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K990342

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031739254]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-09-03

On-Brand Devices [SYNOCTA PROSTHETICS]

• 07630031726018: WN synOcta® Post for temporary restorations, for bridge, H 9mm, Ti
• 07630031726001: WN synOcta® Post for temporary restorations, for crown, H 9mm, Ti
• 07630031725998: RN synOcta® Post for temporary restorations, for bridge, H 9mm, Ti
• 07630031725981: RN synOcta® Post for temporary restorations, for crown, H 9mm, Ti
• 07630031725646: RN synOcta® TS Plastic Coping, H 5.4mm, POM
• 07630031725622: RN synOcta® Plastic Coping for 048.605, for crown, H 7mm, POM
• 07630031725615: RN synOcta® Plastic Coping for 048.605, for bridge, H 7mm, POM
• 07630031725608: RN synOcta® Plastic Coping, Crown, H 13.3mm, POM
• 07630031725592: RN synOcta® Plastic Coping, Bridge/Bar, H 13.3mm, POM
• 07630031725523: RN synOcta® Post for temporary restorations, for crown, H 9mm, Ti
• 07630031725516: RN synOcta® Post for temporary restorations, for bridge, H 9mm, Ti
• 07630031725431: RN synOcta® gold coping, bar, H 5.6mm, Ceramicor®
• 07630031725417: RN synOcta® TS gold coping, for 048.620, H 5.4mm, Ceramicor®
• 07630031725387: RN synOcta® gold coping, crown, for 048.600, H 5.6mm, Ceramicor®/POM
• 07630031725370: RN synOcta® gold coping, bridge, for synOcta 2.5, H 5.6mm, Ceramicor®/POM
• 07630031725349: RN synOcta® Transversal (TS) Abutment, H 4mm, Ti
• 07630031725189: RN synOcta® Abutment, H 2.5mm, Ti
• 07630031723734: RN synOcta® Milling Cylinder, Crown, for synOcta® 1.5, D 6mm, H 8mm, Ti
• 07630031723598: RN synOcta® Ti Coping, Bar for synOcta® 1.5, H 6mm, Ti
• 07630031717252: Bar set, gold, 2x048.601, 2x048.124, 2x048.204, 4x048.350
• 07630031701190: RN synOcta® Cementable Abutment, for crowns/bridges, H 5.5mm, Ti
• 07630031739254: RN synOcta® Cementable Abutment, for crowns/bridges, H 5.5mm, Ti
• 07630031725479: RN synOcta® Milling Cylinder, Crown, for 048.600, D 6mm, H 9.3mm, Ti
• 07630031725462: RN synOcta® Milling Cylinder, Bridge, for 048.600, D 6mm, H 9.3mm, Ti