Bonefit Implant System Accessories & Instruments 048.404

GUDID 07630031776068

RN Octa abutment, height 1.5 mm, titanium

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

Primary Device ID	07630031776068
NIH Device Record Key	76c93565-eabf-4ced-bee4-35bec2a3cb87
Commercial Distribution Status	In Commercial Distribution
Brand Name	Bonefit Implant System Accessories & Instruments
Version Model Number	Straumann Legacy
Catalog Number	048.404
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

Device Dimensions

Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter
Height	1.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031776068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K894844

FDA Product Code

NHA	Abutment, implant, dental, endosseous

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

Moist Heat or Steam Sterilization

[07630031776068]

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

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