CePo Center Point Drils MR-1145

GUDID 07350081495206

2x Center Point Profile Drills for implant diameter =2.2 - System 2

Dentatus AB

Fluted surgical drill bit, reusable
Primary Device ID07350081495206
NIH Device Record Key9a803aa5-2e99-4c33-98c4-775e806c31bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameCePo Center Point Drils
Version Model NumberMR-1145
Catalog NumberMR-1145
Company DUNS355803412
Company NameDentatus AB
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+12124811010
Emaildentatus@dentatus.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107350081495206 [Primary]

FDA Product Code

EJLBur, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07350081495206]

Moist Heat or Steam Sterilization;Dry Heat Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-22
Device Publish Date2016-08-10

Devices Manufactured by Dentatus AB

07350081494896 - IPR Lamineer Tips2024-11-01 2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.25mm Blade Thickness, Single Sided, Left Side
07350081494902 - IPR Lamineer Tips2024-11-01 2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.25mm Blade Thickness, Single Sided, Right Sid
07350081494919 - IPR Lamineer Tips2024-11-01 2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.3mm Blade Thickness, Double Sided 50 Micron D
07350081494926 - IPR Lamineer Tips2024-11-01 2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.4mm Blade Thickness, Double Sided 50 Micron D
07350081494933 - IPR Lamineer Tips2024-11-01 2x Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 0.5mm Blade Thickness, Double Sided 50 Micron D
07350081495329 - Flex Lamineer Tips2024-11-01 2x Flex Lamineer Tips for Profin Reciprocating Contra-Angles Single Sided 75 Micron Diamond Coating
07350081495336 - Flex Lamineer Tips2024-11-01 2x Flex Lamineer Tips for Profin Reciprocating Contra-Angles Single Sided 50 Micron Diamond Coating
07350081495640 - IPR Lamineer Tips2024-11-01 5x Assorted Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 1 of each of the following: 0.1mm Blad

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