On1™ Base Xeal™ 300196

GUDID 07332747126785

On1™ Base Xeal™ Conical Connection WP 2.5mm

Nobel Biocare AB

Dental implant suprastructure, permanent, preformed
Primary Device ID07332747126785
NIH Device Record Key285bf911-cd9c-413e-b79f-00e86d42fae4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOn1™ Base Xeal™
Version Model Number300196
Catalog Number300196
Company DUNS353939929
Company NameNobel Biocare AB
Device Count1
DM Exemptfalse
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

Device Dimensions

Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter
Outer Diameter6.515 Millimeter
Height2.5 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107332747126785 [Primary]

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS
PNPDental abutment design software for dental laboratory

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-10-25
Device Publish Date2020-11-18

On-Brand Devices [On1™ Base Xeal™]

07332747126785On1™ Base Xeal™ Conical Connection WP 2.5mm
07332747126778On1™ Base Xeal™ Conical Connection WP 1.75mm
07332747126761On1™ Base Xeal™ Conical Connection RP 2.5mm
07332747126754On1™ Base Xeal™ Conical Connection RP 1.75mm
07332747126747On1™ Base Xeal™ Conical Connection NP 2.5mm
07332747126730On1™ Base Xeal™ Conical Connection NP 1.75mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.