ZERAMEX® SB/RB/WB Try in Screw RB36554

GUDID 07640161396265

Acessories

CeramTec Schweiz GmbH

Dental prosthesis/implant abutment screw analog, single-use
Primary Device ID07640161396265
NIH Device Record Keyf87ac95f-2400-4769-b166-79f09b126e0b
Commercial Distribution StatusIn Commercial Distribution
Brand NameZERAMEX® SB/RB/WB Try in Screw
Version Model NumberRB36554
Catalog NumberRB36554
Company DUNS483229493
Company NameCeramTec Schweiz GmbH
Device Count1
DM Exempttrue
Pre-market Exempttrue
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+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailm.krauthausen@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de
Phone+41443883636
Emailmpd.regulatory@ceramtec.de

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry, Keep out of sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS107640161396265 [Primary]

FDA Product Code

NDPAccessories, 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 Date2025-02-21
Device Publish Date2025-02-13

Devices Manufactured by CeramTec Schweiz GmbH

07640161396265 - ZERAMEX® SB/RB/WB Try in Screw2025-02-21Acessories
07640161396265 - ZERAMEX® SB/RB/WB Try in Screw2025-02-21 Acessories
07640161396395 - Docklocs® Abutment Torque Wrench Driver2024-12-12 Docklocs® Abutment Torque Wrench Driver
07640161397323 - CERALOG® PL Docklocs® Latch Handpiece Driver, Tri-Lobe (WL)2024-12-12 CERALOG® PL Docklocs® Latch Handpiece Driver, Tri-Lobe (WL)

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.