RN SYNOCTA UCLA GOLD ABUT. FOR STRAUMANN DENTAL IMPLANT 048.642

GUDID 07630031725486

RN synOcta® gold Abutment, crown, H 14.1mm, Ceramicor®/POM

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031725486
• NIH Device Record Key: 73debc5e-1e25-433e-80ef-c7c39ecf1226
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RN SYNOCTA UCLA GOLD ABUT. FOR STRAUMANN DENTAL IMPLANT
• Version Model Number: Final Abutments
• Catalog Number: 048.642
• 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(800)448-8168
• Email: info.usa@straumann.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031725486 [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

[07630031725486]

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

On-Brand Devices [RN SYNOCTA UCLA GOLD ABUT. FOR STRAUMANN DENTAL IMPLANT]

• 07630031725486: RN synOcta® gold Abutment, crown, H 14.1mm, Ceramicor®/POM
• 07630031724243: synOcta® Basal screw L 6,7 mm, TAN