34554

GUDID 07332747000306

Abutment screw PS WP-RP

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed
Primary Device ID07332747000306
NIH Device Record Keya6bc059b-c4ad-43b7-9256-cd556cc783b3
Commercial Distribution Discontinuation2018-03-14
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number34554
Catalog Number34554
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
GS107332747000306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07332747000306]

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

07332747225433 - NobelProcera®2025-05-16 Nobel Dummy Material 2 FDA Integration
07332747207811 - NA2025-05-02 Implant Analog 3.8/4.5 HL
07332747221183 - DTX Studio™ Clinic2025-05-02 DTX Studio Clinic 4.5 for Win 64-bit
07332747221190 - DTX Studio™ Clinic2025-05-02 DTX Studio Clinic 4.5 for Mac
07332747225426 - NA2025-05-02 Nobel Dummy Material for FDA Integration
07332747150377 - Nobel Biocare®2025-04-30 Coping Screw Hex 2mm 4/pkg
07332747207842 - Nobel Biocare®2025-04-03 Direct Abutment Engaging Gold/Plastic 5.0 HL/RPL
07332747207859 - Nobel Biocare®2025-04-03 Direct Abutment Non-Engaging Gold/Plastic 5.0 HL/RPL

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