34551

GUDID 07332747004946

Adapter PS RP-NP

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed
Primary Device ID07332747004946
NIH Device Record Keyab6e11ce-6a18-4626-9500-365b12b31419
Commercial Distribution Discontinuation2016-06-01
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number34551
Catalog Number34551
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 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)322-5001
Emailus.customerservice@nobelbiocare.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747004946 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-11-08
Device Publish Date2015-09-17

Devices Manufactured by Nobel Biocare AB

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07332747215069 - Nobel Biocare®2024-06-28 Nobel Biocare Multi-unit PoLo Bmk WP 8mm
07332747215076 - Nobel Biocare®2024-06-28 Nobel Biocare Multi-unit PoLo Link 10mm
07332747215083 - Nobel Biocare®2024-06-28 Nobel Biocare Multi-unit PoLo Link 15mm
07332747215090 - Nobel Biocare®2024-06-28 Nobel Biocare Multi-unit PoLo Link 20mm
07332747215106 - Nobel Biocare®2024-06-28 Nobel Biocare ReverseScan Multi-unit
07332747215113 - Nobel Biocare®2024-06-28 Nobel Biocare ReverseScan Multi-unit Bmk WP
07332747218008 - Nobel Biocare®2024-06-28 Nobel Biocare Multi-unit PoLo Prosthetic Screw 5/pkg

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