SYNOCTA PROSTHETICS 048.665

GUDID 07630031725646

RN synOcta® TS Plastic Coping, H 5.4mm, POM

Institut Straumann AG

Dental casting wax
Primary Device ID07630031725646
NIH Device Record Key8aa91857-a2cb-4c29-9b29-490b659d0c9b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYNOCTA PROSTHETICS
Version Model Number1
Catalog Number048.665
Company DUNS483599259
Company NameInstitut Straumann AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com
Phone+1(800)448-8168
Emailinfo.usa@straumann.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031725646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

[07630031725646]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [SYNOCTA PROSTHETICS]

07630031726018WN synOcta® Post for temporary restorations, for bridge, H 9mm, Ti
07630031726001WN synOcta® Post for temporary restorations, for crown, H 9mm, Ti
07630031725998RN synOcta® Post for temporary restorations, for bridge, H 9mm, Ti
07630031725981RN synOcta® Post for temporary restorations, for crown, H 9mm, Ti
07630031725646RN synOcta® TS Plastic Coping, H 5.4mm, POM
07630031725622RN synOcta® Plastic Coping for 048.605, for crown, H 7mm, POM
07630031725615RN synOcta® Plastic Coping for 048.605, for bridge, H 7mm, POM
07630031725608RN synOcta® Plastic Coping, Crown, H 13.3mm, POM
07630031725592RN synOcta® Plastic Coping, Bridge/Bar, H 13.3mm, POM
07630031725523RN synOcta® Post for temporary restorations, for crown, H 9mm, Ti
07630031725516RN synOcta® Post for temporary restorations, for bridge, H 9mm, Ti
07630031725431RN synOcta® gold coping, bar, H 5.6mm, Ceramicor®
07630031725417RN synOcta® TS gold coping, for 048.620, H 5.4mm, Ceramicor®
07630031725387RN synOcta® gold coping, crown, for 048.600, H 5.6mm, Ceramicor®/POM
07630031725370RN synOcta® gold coping, bridge, for synOcta 2.5, H 5.6mm, Ceramicor®/POM
07630031725349RN synOcta® Transversal (TS) Abutment, H 4mm, Ti
07630031725189RN synOcta® Abutment, H 2.5mm, Ti
07630031723734RN synOcta® Milling Cylinder, Crown, for synOcta® 1.5, D 6mm, H 8mm, Ti
07630031723598RN synOcta® Ti Coping, Bar for synOcta® 1.5, H 6mm, Ti
07630031717252Bar set, gold, 2x048.601, 2x048.124, 2x048.204, 4x048.350
07630031701190RN synOcta® Cementable Abutment, for crowns/bridges, H 5.5mm, Ti
07630031739254RN synOcta® Cementable Abutment, for crowns/bridges, H 5.5mm, Ti
07630031725479RN synOcta® Milling Cylinder, Crown, for 048.600, D 6mm, H 9.3mm, Ti
07630031725462RN synOcta® Milling Cylinder, Bridge, for 048.600, D 6mm, H 9.3mm, Ti
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