Straumann Screw-Retained Abutments 024.0019-04

GUDID 07630031755810

Protective Cap for Screw-retained Abutment, Ø 3.5mm, H 5mm, wide, PEEK/TAN

Institut Straumann AG

Dental implant suprastructure, temporary, preformed, single-use

Primary Device ID	07630031755810
NIH Device Record Key	78eeaa4c-d16d-4bb8-b156-cc30151aec85
Commercial Distribution Status	In Commercial Distribution
Brand Name	Straumann Screw-Retained Abutments
Version Model Number	Protective caps
Catalog Number	024.0019-04
Company DUNS	483599259
Company Name	Institut Straumann AG
Device Count	4
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	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(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com
Phone	+1(801)448-8168
Email	info.usa@straumann.com

Device Dimensions

Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	5 Millimeter
Outer Diameter	3.5 Millimeter
Height	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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031746023 [Primary]
GS1	07630031755810 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K192401

FDA Product Code

NHA	Abutment, implant, dental, endosseous

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

[07630031755810]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-04-11
Device Publish Date	2022-04-01

On-Brand Devices [Straumann Screw-Retained Abutments]

07630031746078	Temporary Coping for Screw-retained Abutment, Bridge, Ø 4.6mm, TAN
07630031746061	Temporary Coping for Screw-retained Abutment, Crown, Ø 4.6mm, TAN
07630031746054	Temporary Coping for Screw-retained Abutment, Bridge, Ø 3.5mm, TAN
07630031746047	Temporary Coping for Screw-retained Abutment, Crown, Ø 3.5mm, TAN
07630031755810	Protective Cap for Screw-retained Abutment, Ø 3.5mm, H 5mm, wide, PEEK/TAN
07630031745828	RC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 5.5mm, Type B, sterile
07630031745811	RC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 5.5mm, Type A, sterile
07630031745804	RC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 4.5mm, Type B, sterile
07630031745798	RC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 4.5mm, Type A, sterile
07630031745781	RC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 3.5mm, Type B, sterile
07630031745774	RC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 3.5mm, Type A, sterile
07630031745767	RC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 5.5mm, Type B, sterile
07630031745750	RC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 5.5mm, Type A, sterile
07630031745743	RC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 4.5mm, Type B, sterile
07630031745736	RC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 4.5mm, Type A, sterile
07630031745729	RC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 3.5mm, Type B, sterile
07630031745712	RC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 3.5mm, Type A, sterile
07630031745705	RC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 2.5mm, Type B, sterile
07630031745699	RC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 2.5mm, Type A, sterile
07630031745682	NC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 5.5mm, Type B, sterile
07630031745675	NC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 5.5mm, Type A, sterile
07630031745668	NC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 4.5mm, Type B, sterile
07630031745651	NC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 4.5mm, Type A, sterile
07630031745644	NC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 3.5mm, Type B, sterile
07630031745637	NC Screw-ret. Abut., TAN, angled 30°, Ø 4.6mm, GH 3.5mm, Type A, sterile
07630031745620	NC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 5.5mm, Type B, sterile
07630031745613	NC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 5.5mm, Type A, sterile
07630031745606	NC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 4.5mm, Type B, sterile
07630031745590	NC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 4.5mm, Type A, sterile
07630031745583	NC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 3.5mm, Type B, sterile
07630031745576	NC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 3.5mm, Type A, sterile
07630031745569	NC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 2.5mm, Type B, sterile
07630031745552	NC Screw-ret. Abut., TAN, angled 17°, Ø 4.6mm, GH 2.5mm, Type A, sterile
07630031745538	RC Screw-ret. Abut., TAN, straight 0°, Ø 4.6mm, GH 3.5mm, sterile
07630031745521	RC Screw-ret. Abut., TAN, straight 0°, Ø 4.6mm, GH 2.5mm, sterile
07630031745514	RC Screw-ret. Abut., TAN, straight 0°, Ø 4.6mm, GH 1.5mm, sterile
07630031745491	NC Screw-ret. Abut., TAN, straight 0°, Ø 4.6mm, GH 3.5mm, sterile
07630031745484	NC Screw-ret. Abut., TAN, straight 0°, Ø 4.6mm, GH 2.5mm, sterile
07630031745477	NC Screw-ret. Abut., TAN, straight 0°, Ø 4.6mm, GH 1.5mm, sterile
07630031745453	NC Screw-ret. Abut., TAN, straight 0°, Ø 3.5mm, GH 3.5mm, sterile
07630031745446	NC Screw-ret. Abut., TAN, straight 0°, Ø 3.5mm, GH 2.5mm, sterile
07630031745439	NC Screw-ret. Abut., TAN, straight 0°, Ø 3.5mm, GH 1.5mm, sterile
07630031755827	Protective Cap for Screw-retained Abutment, Ø 4.6mm, H 5.1mm, wide, PEEK/TAN

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