P.004 ABUTMENTS, TEMPORARY COPINGS, PROTECTIVE CA 023.4764

GUDID 07630031709943

RC Coping, for bridge on Multi-Base Abutment, straight, D 6.5mm, POM

Institut Straumann AG

Dental casting wax

• Primary Device ID: 07630031709943
• NIH Device Record Key: e4d60e3c-0598-4449-827d-9ef12c12be7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.004 ABUTMENTS, TEMPORARY COPINGS, PROTECTIVE CA
• Version Model Number: 1
• Catalog Number: 023.4764
• 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
• 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

• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 6.5 Millimeter

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
• 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	07630031709943 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080239

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [P.004 ABUTMENTS, TEMPORARY COPINGS, PROTECTIVE CA]

• 07630031710857: RC Protective Cap, for Multi-base Abutment, straight, D 6.5mm, PEEK/TAN
• 07630031710833: RC Temporary Coping, for Multi-Base Abutment, straight, D 4.5mm, Ti
• 07630031710734: RC Protective Cap, for Multi-base Abutment, angled 25 deg., PEEK/TAN
• 07630031710406: NC Temporary Coping, for Multi-Base Abutment, straight, D 4.5mm, Ti
• 07630031710390: NC Protective Cap, for Multi-Base Abutment, straight, D 4.5mm, PEEK/TAN
• 07630031710376: NC Protective Cap, for Multi-Base Abutment, straight, D 3.5mm, PEEK/TAN
• 07630031710291: NC Temporary Coping, for Multi-Base Abutment, angled 25 deg., Ti
• 07630031710284: NC Protective Cap, for Multi-Base Abutment, angled 25 deg., PEEK/TAN
• 07630031709943: RC Coping, for bridge on Multi-Base Abutment, straight, D 6.5mm, POM
• 07630031709745: RC Coping, for bridge on Multi-Base Abutment, straight, D 4.5mm, POM
• 07630031709707: RC Coping, for bridge on Multi-Base Abutment, angled 25 deg., POM
• 07630031709516: NC Coping, for bridge on Multi-Base Abutment, straight, D 4.5mm, POM
• 07630031709479: NC Coping, for bridge on Multi-Base Abutment, straight, D 3.5mm, POM
• 07630031709431: NC Coping, for bridge on Multi-Base Abutment, angled 25 deg., POM