P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALI 024.4270

GUDID 07630031710710

RC Healing Abutment, customizable, D 7mm, PEEK

Institut Straumann AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07630031710710
• NIH Device Record Key: aa3fa822-c400-477e-a381-69f7dac6572f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.004 RC TEMPORARY ABUTMENT, P.004 TEMPORARY HEALI
• Version Model Number: 1
• Catalog Number: 024.4270
• 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

• Outer Diameter: 7 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031710710 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070478

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031710710]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-12-07
• Device Publish Date: 2015-09-24

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