NC, RC, WN, RN, NNC TEMPORARY ABUTMENT, CAD-TEMP, 024.2372

GUDID 07630031710451

NC Temporary abutment D 5mm, H 12mm, VITA CAD-Temp®, PMMA/TAN

Institut Straumann AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07630031710451
• NIH Device Record Key: 90a44cf5-b78c-4f06-8641-14638fd22312
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NC, RC, WN, RN, NNC TEMPORARY ABUTMENT, CAD-TEMP,
• Version Model Number: 1
• Catalog Number: 024.2372
• 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: 5 Millimeter
• 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	07630031710451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122192

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031710451]

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

Devices Manufactured by Institut Straumann AG

• 07630031772534 - NA: 2024-06-13 TLX SP Guided Implant Driver, for adapter, H4 stop, stainless steel
• 07630031772541 - NA: 2024-06-13 TLX S Guided Implant Driver, for adapter, H4 stop, stainless steel
• 07630031772671 - NA: 2024-06-13 BLX Guided Implant Driver, for adapter, H4 stop, stainless steel
• 07630031764713 - Straumann® BLC and TLC Implants - Line extension: 2024-05-13 BLC Implant, Ø 6.5mm WB, SLActive 16mm, Roxolid
• 07630031765710 - Straumann® BLC and TLC Implants - Line extension: 2024-05-13 TLC S Implant, Ø 5.5mm WT, SLActive 14mm, Roxolid
• 07630031765727 - Straumann® BLC and TLC Implants - Line extension: 2024-05-13 TLC S Implant, Ø 5.5mm WT, SLActive 16mm, Roxolid
• 07630031765741 - Straumann® BLC and TLC Implants - Line extension: 2024-05-13 TLC S Implant, Ø 6.5mm WT, SLActive 8mm, Roxolid
• 07630031765758 - Straumann® BLC and TLC Implants - Line extension: 2024-05-13 TLC S Implant, Ø 6.5mm WT, SLActive 10mm, Roxolid