NobelPearl Tapered WP 5.5x12mm 300761

GUDID 07640161392960

Dental Implant

Dentalpoint AG

Dental implant system
Primary Device ID07640161392960
NIH Device Record Keyfc4638ff-f53f-446e-a7f7-fdebd9b1a3a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNobelPearl Tapered WP 5.5x12mm
Version Model Number300761
Catalog Number300761
Company DUNS483229493
Company NameDentalpoint AG
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+41443883630
Emailpascal.wettstein@zeramex.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS107640161392960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEIMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-31
Device Publish Date2018-11-30

On-Brand Devices [NobelPearl Tapered WP 5.5x12mm]

07640161392960Dental Implant
07640161395176Dental Implant

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