ZERAMEX® WB Provisional (incl. Screw) WB37530

GUDID 07640161392250

Prosthetics

Dentalpoint AG

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID07640161392250
NIH Device Record Key5d135780-27b6-4840-b248-25f341d0901f
Commercial Distribution StatusIn Commercial Distribution
Brand NameZERAMEX® WB Provisional (incl. Screw)
Version Model NumberWB37530
Catalog NumberWB37530
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

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
GS107640161392250 [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

Devices Manufactured by Dentalpoint AG

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07640161393776 - ZERAMEX®XT Rescue-Shell XT WIDE2024-05-15 ZERAMEX®XT Rescue-Shell XT WIDE
07640161395077 - ZERAMEX®XT Rescue-Shell XT SMALL2024-05-15 ZERAMEX®XT Rescue-Shell XT SMALL
07640161396401 - CERALOG PL Implant, Ø 3.8 L 92024-05-07 Dental Implant
07640161396432 - CERALOG PL Implant, Ø 3.8 L 112024-05-07 Dental Implant
07640161396449 - CERALOG PL Implant, Ø 3.8 L 132024-05-07 Dental Implant
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

Trademark Results [ZERAMEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZERAMEX
ZERAMEX
79184529 5093433 Live/Registered
Dentalpoint AG
2015-12-09
ZERAMEX
ZERAMEX
77522688 4522136 Live/Registered
Dentalpoint AG
2008-07-15

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