SYNOCTA ABUTMENTS 048.601

GUDID 07630031725196

RN synOcta® 1.5 screw-retained Abutment, H 1.5mm, TAN

Institut Straumann AG

Dental implant suprastructure, permanent, preformed
Primary Device ID07630031725196
NIH Device Record Key3d7dfe17-fedb-49be-9d92-e6c680b7f7ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYNOCTA ABUTMENTS
Version Model NumberFinal Abutments
Catalog Number048.601
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 Datefalse
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

Device Dimensions

Angle15 degree
Angle15 degree

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031725196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031725196]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-09-24

Devices Manufactured by Institut Straumann AG

07630031772558 - NA2025-04-03 Pilot Twist Drill PRO, Ø 2.2mm, short, L 34mm, stainless steel
07630031772565 - NA2025-04-03 Pilot Twist Drill PRO, Ø 2.2mm, medium, L 38mm, stainless steel
07630031772572 - NA2025-04-03 Pilot Twist Drill PRO, Ø 2.2mm, long, L 42mm, stainless steel
07630031772589 - NA2025-04-03 Twist Drill PRO, Ø 2.8mm, short, L 34mm, stainless steel
07630031772596 - NA2025-04-03 Twist Drill PRO, Ø 2.8mm, medium, L 38mm, stainless steel
07630031772602 - NA2025-04-03 Twist Drill PRO, Ø 2.8mm, long, L 42mm, stainless steel
07630031772619 - NA2025-04-03 Twist Drill PRO, Ø 3.5mm, short, L 34mm, stainless steel
07630031772626 - NA2025-04-03 Twist Drill PRO, Ø 3.5mm, medium, L 38mm, stainless steel

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