P.004 ABUTMENTS, TEMPORARY COPINGS, PROTECTIVE CAPS, PERMANENT COPINGS 023.4701

GUDID 07630031709684

RC Coping, for bridge on multi-base Abutment, angled 25 deg., Ceramicor®/POM

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031709684
• NIH Device Record Key: 097bded4-6eeb-45f1-a337-be4e7eefc37d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.004 ABUTMENTS, TEMPORARY COPINGS, PROTECTIVE CAPS, PERMANENT COPINGS
• Version Model Number: Final Copings
• Catalog Number: 023.4701
• 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
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com

Device Dimensions

• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree
• Angle: 25 degree

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031709684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080239

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

Moist Heat or Steam Sterilization

[07630031709684]

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 [P.004 ABUTMENTS, TEMPORARY COPINGS, PROTECTIVE CAPS, PERMANENT COPINGS]

• 07630031711052: NC/RC Occlusal Screw, for coping on, Multi-Base Abutment, TAN
• 07630031710864: RC Temporary Coping, for Multi-Base Abutment, straight, D 6.5mm, Ti
• 07630031710826: RC Protective Cap, for Multi-base Abutment, straight, D 4.5mm, PEEK/TAN
• 07630031710741: RC Temporary Coping, for Multi-Base Abutment, angled 25 deg., Ti
• 07630031710383: NC Temporary Coping, for Multi-Base Abutment, straight, D 3.5mm, Ti
• 07630031709950: RC Coping, for bar on Multi-Base Abutment, straight, D 6.5mm, Ti
• 07630031709929: RC Coping, for bar on multi-base Abutment, straight, D 6.5mm, Ceramicor®
• 07630031709912: RC Coping, for bridge on multi-base Abutment, straight, D 6.5mm, Ceramicor®/POM
• 07630031709752: RC Coping, for bar on Multi-Base Abutment, straight, D 4.5mm, Ti
• 07630031709738: RC Coping, for bar on multi-base Abutment, straight, D 4.5mm, Ceramicor®
• 07630031709721: RC Coping, for bridge on multi-base Abutment, straight, D 4.5mm, Ceramicor®/POM
• 07630031709714: RC Coping, for bar on Multi-Base Abutment, angled 25 deg., Ti
• 07630031709691: RC Coping, for bar on multi-base Abutment, angled 25 deg., Ceramicor®
• 07630031709684: RC Coping, for bridge on multi-base Abutment, angled 25 deg., Ceramicor®/POM
• 07630031709523: NC Coping, for bar on Multi-Base Abutment, straight, D 4.5mm, Ti
• 07630031709509: NC Coping, for bar on multi-base Abutment, straight, D 4.5mm, Ceramicor®
• 07630031709493: NC Coping, for bridge on multi-base Abutment, straight, D 4.5mm, Ceramicor®/POM
• 07630031709486: NC Coping, for bar on Multi-Base Abutment, straight, D 3.5mm, Ti
• 07630031709462: NC Coping, for bar on multi-base Abutment, straight, D 3.5mm, Ceramicor®
• 07630031709455: NC Coping, for bridge on multi-base Abutment, straight, D 3.5mm, Ceramicor®/POM
• 07630031709448: NC Coping, for bar on Multi-Base Abutment, angled 25 deg., Ti
• 07630031709424: NC Coping, for bar on multi-base Abutment, angled 25 deg., Ceramicor®
• 07630031709417: NC Coping, for bridge on multi-base Abutment, angled 25 deg., Ceramicor®/POM
• 07630031709219: RC Multi-Base Abutment, Type B, angled 25 deg., TAN
• 07630031709202: RC Multi-Base Abutment, Type A, angled 25 deg., TAN
• 07630031709196: RC Multi-Base Abutment, straight, D 6.5mm, GH 4mm, TAN
• 07630031709189: RC Multi-Base Abutment, straight, D 6.5mm, GH 2.5mm, TAN
• 07630031709172: RC Multi-Base Abutment, straight, D 6.5mm, GH 1mm, TAN
• 07630031708946: RC Multi-Base Abutment, straight, D 4.5mm, GH 4mm, TAN
• 07630031708939: RC Multi-Base Abutment, straight, D 4.5mm, GH 2.5mm, TAN
• 07630031708922: RC Multi-Base Abutment, straight, D 4.5mm, GH 1mm, TAN
• 07630031708502: NC Multi-Base Abutment, Type B, angled 25 deg., TAN
• 07630031708496: NC Multi-Base Abutment, Type A, angled 25 deg., TAN
• 07630031708205: NC Multi-Base Abutment, straight, D 4.5mm, GH 4mm, TAN
• 07630031708199: NC Multi-Base Abutment, straight, D 4.5mm, GH 2.5mm, TAN
• 07630031708182: NC Multi-Base Abutment, straight, D 4.5mm, GH 1mm, TAN
• 07630031708175: NC Multi-Base Abutment, straight, D 3.5mm, GH 4mm, TAN
• 07630031708168: NC Multi-Base Abutment, straight, D 3.5mm, GH 2.5mm, TAN
• 07630031708151: NC Multi-Base Abutment, straight, D 3.5mm, GH 1mm, TAN