38716

GUDID 07332747113518

On1 Esthetic Abutment Zirconia 0.3 mm NP

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed
Primary Device ID07332747113518
NIH Device Record Key56b28abf-9b38-4b12-9d6c-e1435668c790
Commercial Distribution Discontinuation2018-06-12
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number38716
Catalog Number38716
Company DUNS353939929
Company NameNobel Biocare AB
Device Count1
DM Exempttrue
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)322-5001
Emailus.customerservice@nobelbiocare.com

Device Dimensions

Height0.3 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747113518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07332747113518]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2019-11-08
Device Publish Date2017-10-25

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