ZERAMEX® SB Gingivaformer, 4mm SB35504

GUDID 07640161394223

ZERAMEX® SB Gingivaformer, 4mm

Dentalpoint AG

Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID07640161394223
NIH Device Record Keyfa93107d-9155-4185-abe7-91a5f4f8550d
Commercial Distribution StatusIn Commercial Distribution
Brand NameZERAMEX® SB Gingivaformer, 4mm
Version Model NumberSB35504
Catalog NumberSB35504
Company DUNS483229493
Company NameDentalpoint AG
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107640161394223 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-21
Device Publish Date2020-10-13

Devices Manufactured by Dentalpoint AG

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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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