ZERADRILL™ S14 (SMALL 14mm) T35614

GUDID 07640161391345

Tools

Dentalpoint AG

Steel dental bur
Primary Device ID07640161391345
NIH Device Record Keyae082efb-8433-4741-badf-0194d8285f99
Commercial Distribution StatusIn Commercial Distribution
Brand NameZERADRILL™ S14 (SMALL 14mm)
Version Model NumberT35614
Catalog NumberT35614
Company DUNS483229493
Company NameDentalpoint AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
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
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107640161391345 [Primary]

FDA Product Code

NDPAccessories, implant, dental, endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640161391345]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-03-23
Device Publish Date2018-11-30

Devices Manufactured by Dentalpoint AG

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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
07640161396470 - CERALOG PL Implant, Ø 4.3 L 132024-05-07 Dental Implant
07640161396487 - CERALOG PL Implant, Ø 5.0 L 92024-05-07 Dental Implant
07640161396494 - CERALOG PL Implant, Ø 5.0 L 112024-05-07 Dental Implant

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