Cementable Abuntments; Temporary Copings; Protective Caps 010.6101

GUDID 07630031739070

NC Cementable Abutment, Ø 5mm, GH 1mm, AH 4mm, Ti

Institut Straumann AG

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031739070
• NIH Device Record Key: 19dec499-e761-47e0-8eee-136a8782d23a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cementable Abuntments; Temporary Copings; Protective Caps
• Version Model Number: Final Abutments
• Catalog Number: 010.6101
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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

Device Dimensions

• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter
• Height: 1 Millimeter
• Outer Diameter: 5 Millimeter
• Height: 4 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031739070 [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

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

[07630031739070]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-04
• Device Publish Date: 2023-07-27

On-Brand Devices [Cementable Abuntments; Temporary Copings; Protective Caps]

• 07630031713636: NC Cementable All-In-One Set, for crown, D 5mm, AH 5.5mm, GH 3mm
• 07630031713629: NC Cementable All-In-One Set, for crown, D 5mm, AH 5.5mm, GH 2mm
• 07630031713605: NC Cementable All-In-One Set, for crown, D 5mm, AH 4mm, GH 3mm
• 07630031713582: NC Cementable All-In-One Set, for crown, D 5mm, AH 4mm, GH 1mm
• 07630031713575: NC Cementable All-In-One Set, for crown, D 3.5mm, AH 4mm, GH 3mm
• 07630031713568: NC Cementable All-In-One Set, for crown, D 3.5mm, AH 4mm, GH 2mm
• 07630031711823: NC Basal Screw, for Cementable Abutment only, TAN
• 07630031700506: NC Cementable Abutment, D 5mm, GH 3mm, AH 5.5mm, Ti
• 07630031700490: NC Cementable Abutment, D 5mm, GH 2mm, AH 5.5mm, Ti
• 07630031700483: NC Cementable Abutment, D 5mm, GH 1mm, AH 5.5mm, Ti
• 07630031700476: NC Cementable Abutment, D 5mm, GH 3mm, AH 4mm, Ti
• 07630031700469: NC Cementable Abutment, D 5mm, GH 2mm, AH 4mm, Ti
• 07630031700452: NC Cementable Abutment, D 5mm, GH 1mm, AH 4mm, Ti
• 07630031700445: NC Cementable Abutment, D 3.5mm, GH 3mm, AH 5.5mm, Ti
• 07630031700438: NC Cementable Abutment, D 3.5mm, GH 2mm, AH 5.5mm, Ti
• 07630031700421: NC Cementable Abutment, D 3.5mm, GH 1mm, AH 5.5mm, Ti
• 07630031700414: NC Cementable Abutment, D 3.5mm, GH 3mm, AH 4mm, Ti
• 07630031700407: NC Cementable Abutment, D 3.5mm, GH 2mm, AH 4mm, Ti
• 07630031700391: NC Cementable Abutment, D 3.5mm, GH 1mm, AH 4mm, Ti
• 07630031739322: NC Cementable Abutment, Ø 3.5mm, GH 3mm, AH 5.5mm, Ti
• 07630031739315: NC Cementable Abutment, Ø 3.5mm, GH 2mm, AH 5.5mm, Ti
• 07630031739308: NC Cementable Abutment, Ø 3.5mm, GH 1mm, AH 5.5mm, Ti
• 07630031739292: NC Cementable Abutment, Ø 3.5mm, GH 3mm, AH 4mm, Ti
• 07630031739285: NC Cementable Abutment, Ø 3.5mm, GH 2mm, AH 4mm, Ti
• 07630031739278: NC Cementable Abutment, Ø 3.5mm, GH 1mm, AH 4mm, Ti
• 07630031739124: NC Cementable Abutment, Ø 5mm, GH 3mm, AH 5.5mm, Ti
• 07630031739117: NC Cementable Abutment, Ø 5mm, GH 2mm, AH 5.5mm, Ti
• 07630031739100: NC Cementable Abutment, Ø 5mm, GH 1mm, AH 5.5mm, Ti
• 07630031739094: NC Cementable Abutment, Ø 5mm, GH 3mm, AH 4mm, Ti
• 07630031739087: NC Cementable Abutment, Ø 5mm, GH 2mm, AH 4mm, Ti
• 07630031739070: NC Cementable Abutment, Ø 5mm, GH 1mm, AH 4mm, Ti