ZERADRILL™ R14 (REGULAR 14mm) T36614

GUDID 07640161391406

Tools

Dentalpoint AG

Steel dental bur
Primary Device ID07640161391406
NIH Device Record Key639320b1-3a33-4d87-8d85-57674315c94f
Commercial Distribution StatusIn Commercial Distribution
Brand NameZERADRILL™ R14 (REGULAR 14mm)
Version Model NumberT36614
Catalog NumberT36614
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

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
GS107640161391406 [Primary]

FDA Product Code

NDPAccessories, implant, dental, endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07640161391406]

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

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
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.