CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTI 027.4308

GUDID 07630031713599

NC Cementable All-In-One Set, for crown, D 5mm, AH 4mm, GH 2mm

Institut Straumann AG

Dental implant suprastructure kit

• Primary Device ID: 07630031713599
• NIH Device Record Key: cd4f2610-23eb-48d1-abed-45d1c1484826
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTI
• Version Model Number: 1
• Catalog Number: 027.4308
• 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: true
• 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

Device Dimensions

• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• 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
• 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	07630031713599 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080286

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

[07630031713599]

Moist Heat or Steam Sterilization

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 [CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTI]

• 07630031713612: NC Cementable All-In-One Set, for crown, D 5mm, AH 5.5mm, GH 1mm
• 07630031713599: NC Cementable All-In-One Set, for crown, D 5mm, AH 4mm, GH 2mm
• 07630031713551: NC Cementable All-In-One Set, for crown, D 3.5mm, AH 4mm, GH 1mm
• 07630031710420: NC Temporary Coping, for Cementable Abutment, D 5mm, PMMA
• 07630031710413: NC Temporary Coping, for Cementable Abutment, D 3.5mm, PMMA
• 07630031710369: NC Protective Cap, for Cementable Abutment, D 5mm, AH 5.5mm, PEEK
• 07630031710321: NC Protective Cap, for Cementable Abutment, D 5mm, AH 4mm, PEEK
• 07630031710314: NC Protective Cap, for Cementable Abutment, D 3.5mm, AH 5.5mm, PEEK
• 07630031710307: NC Protective Cap, for Cementable Abutment, D 3.5mm, AH 4mm, PEEK
• 07630031709400: NC Coping, for crown on Cementable Abutment, D 5mm, POM
• 07630031709394: NC Coping, for bridge on Cementable Abutment, D 5mm, POM
• 07630031709370: NC Coping, for bridge on Cementable Abutment, D 3.5mm, POM