35028

GUDID 07332747024029

Temp Abut NobelActive Internal Non-E RP

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed
Primary Device ID07332747024029
NIH Device Record Keyfad54c41-8d44-4c53-850b-ce70eb61bcb5
Commercial Distribution Discontinuation2018-03-14
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number35028
Catalog Number35028
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 Identifiers

Device Issuing AgencyDevice ID
GS107332747024029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07332747024029]

Moist Heat or Steam Sterilization


Device Entry Metadata

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

Devices Manufactured by Nobel Biocare AB

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07332747207958 - NobelReplace®2025-07-31 NOBELREPLACE® Manual Torque Wrench Adapter Surgical
07332747208085 - NA2025-07-31 Screwdriver Manual Ball Abutment 22 mm
07332747208092 - NA2025-07-31 Screwdriver Machine Ball Abutment 24 mm
07332747208290 - NA2025-07-31 Connection to Handpiece
07332747208306 - NA2025-07-31 Impression Coping Open Tray Multi-unit
07332747208313 - Brånemark System®2025-07-31 Impression Coping Open Tray Multi-u Brånemark System® WP

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