NARROW NECK TEMPORARY COPING 048.669

GUDID 07630031725684

NN Temporary Coping, H 10mm, PEEK/TAN

Institut Straumann AG

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID07630031725684
NIH Device Record Keyf797d19d-4a6b-433d-af12-a1579ee2ab47
Commercial Distribution StatusIn Commercial Distribution
Brand NameNARROW NECK TEMPORARY COPING
Version Model NumberTemporary Coping
Catalog Number048.669
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

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107630031725684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630031725684]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-04
Device Publish Date2015-09-24

Devices Manufactured by Institut Straumann AG

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07630031703064 - Base metal alloy2025-06-16 ticon Titanium primary crown
07630031742261 - Straumann TLX Implant System2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 6mm, Roxolid®
07630031742292 - Straumann TLX Implant System2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 12mm, Roxolid®
07630031742308 - Straumann TLX Implant System2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 14mm, Roxolid®
07630031742315 - Straumann TLX Implant System2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 16mm, Roxolid®
07630031742322 - Straumann TLX Implant System2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 18mm, Roxolid®

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