NobelPearl Temporary Abutment Inter-X WP 300715

GUDID 07640161393219

Prosthetics

Dentalpoint AG

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID07640161393219
NIH Device Record Key9d2a80c7-e285-48b9-ae3c-5bc637e5b0c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameNobelPearl Temporary Abutment Inter-X WP
Version Model Number300715
Catalog Number300715
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 Datefalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107640161393219 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

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

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07640161396401 - CERALOG PL Implant, Ø 3.8 L 92024-05-07 Dental Implant
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07640161396456 - CERALOG PL Implant, Ø 4.3 L 92024-05-07 Dental Implant
07640161396463 - CERALOG PL Implant,Ø 4.3 L 112024-05-07 Dental Implant

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