Bonefit Implant System Accessories & Instruments 048.370V4

GUDID 07630031776051

SCS Bone Graft Closure screw, large, titanium

Institut Straumann AG

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 07630031776051
• NIH Device Record Key: 6471385b-9c06-4c06-b4f3-1e198be37aaa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bonefit Implant System Accessories & Instruments
• Version Model Number: Healing Components
• Catalog Number: 048.370V4
• 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: false
• 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
• 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
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031776051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K894844

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

[07630031776051]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-09
• Device Publish Date: 2023-09-30

On-Brand Devices [Bonefit Implant System Accessories & Instruments]

• 07630031724953: WN Solid Abutment 6 deg., H 5.5mm, brown, Ti
• 07630031724946: WN Solid Abutment 6 deg., H 4mm, green, Ti
• 07630031724939: RN Solid Abutment 6 deg., H 7mm, blue, Ti
• 07630031724922: RN Solid Abutment 6 deg., H 5.5mm, grey, Ti
• 07630031724915: RN Solid Abutment 6 deg., H 4mm, yellow, Ti
• 07630031724816: NN Coping, H 9mm, Ti
• 07630031724786: NN Framework blank, can be trimmed, H 9mm, Estheticor® Cosmor H
• 07630031724601: Titanium matrix for retentive anchor, height 3.1 mm, titanium
• 07630031724595: Retentive anchor, H 3.4mm, Ti
• 07630031724472: Goldmatrix for retentive anchor, H 3.1mm, Elitor®
• 07630031724441: NN Closure screw, with internal hexagon H 1.8mm, Ti
• 07630031724434: RN closure screw, large, height 1.5 mm, titanium
• 07630031724397: RN closure screw, small, titanium
• 07630031724335: SCS Guide screw, can be shortened by 2 mm, L 14 mm, Ti
• 07630031724328: SCS Guide screw, can be shortened by 2 mm, L 12 mm, Ti
• 07630031724311: SCS Guide screw, can be shortened by 2 mm, L 10 mm, Ti
• 07630031724304: SCS Guide screw for 048.240/241, can be shortened by 2 mm, L 8 mm, Ti
• 07630031724298: SCS Guide screw for 048.240/241, cannot be shortened, L 8 mm, Ti
• 07630031724274: SCS Guide screw for RN synOcta® Bar coping can be shortened by 1.6 mm, L 6 mm, Ti
• 07630031724267: SCS Guide screw for RN synOcta® Bar coping cannot be shortened, L 6 mm, Ti
• 07630031724199: SCS Occlusal screw, length 4.4 mm, titanium
• 07630031723659: RN synOcta® Plastic Coping for synOcta® 1.5, for crown, H 10mm, POM
• 07630031723642: RN synOcta® Plastic Coping for synOcta® 1.5, for bridge/bar, H 10mm, POM
• 07630031723567: Gold coping for bar abutment 8 deg., H 5mm, Ceramicor®
• 07630031723550: RN synOcta® gold coping, bar, for synOcta 1.5, H 5.8mm, Ceramicor®
• 07630031722379: WN Healing cap, H 3mm, Ti
• 07630031717887: WN Solid All-In-One Set, brown, H 5.5mm, for bridge
• 07630031717870: WN Solid All-In-One Set, green, H 4mm, for bridge
• 07630031717863: RN Solid All-In-One Set, blue, H 7mm, for bridge
• 07630031717856: RN Solid All-In-One Set, gray, H 5.5mm, for bridge
• 07630031717849: RN Solid All-In-One Set, yellow, H 4mm, for bridge
• 07630031717832: WN Solid All-In-One Set, brown, H 5.5mm, for crown
• 07630031717825: WN Solid All-In-One Set, green, H 4mm, for crown
• 07630031717818: RN Solid All-In-One Set, blue, H 7mm, for crown
• 07630031717801: RN Solid All-In-One Set, gray, H 5.5mm, for crown
• 07630031717795: RN Solid All-In-One Set, yellow, H 4mm, for crown
• 07630031717382: NN Closure screw set, consisting of: 2 NN Closure screws, height 1.8mm, internal hexagon, titani
• 07630031728890: RN Retentive anchor, H 6.4 mm, Ti
• 07630031776068: RN Octa abutment, height 1.5 mm, titanium
• 07630031776051: SCS Bone Graft Closure screw, large, titanium