38703

GUDID 07332747113389

On1 Temporary Abutment Engaging RP

Nobel Biocare AB

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID07332747113389
NIH Device Record Key09d76a2e-caa6-4c3d-9394-e9665f4c23c7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number38703
Catalog Number38703
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
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com
Phone+1(800)322-5001
Emailus.customerservice@nobelbiocare.com

Device Dimensions

Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter
Height6.5 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747113389 [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 Number5
Public Version Date2019-05-31
Device Publish Date2017-10-31

Devices Manufactured by Nobel Biocare AB

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
07332747207866 - Nobel Biocare®2025-04-03 Direct Abutment Engaging Gold/Plastic 6.0 HL/RPL
07332747207873 - Nobel Biocare®2025-04-03 Direct Abutment Non-Engaging Gold/Plastic 6.0 HL/RPL
07332747208108 - Nobel Biocare®2025-04-03 Temporary Abutment Engaging Brånemark System® NP
07332747208115 - Nobel Biocare®2025-04-03 Temporary Abutment Non-Engaging Bmk Syst NP
07332747208122 - Nobel Biocare®2025-04-03 Temporary Abutment Engaging Brånemark System® RP
07332747208139 - Nobel Biocare®2025-04-03 Temporary Abutment Non-Engaging Bmk Syst RP

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.