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

07350081492335 - Surtex2025-02-07 Surtex Gold Plated Post Dispenser Intro Kit - 18 Posts/Kit plus Accessories - Post Material: Brass with Gold Plating - Sizes: Sh
07350081495596 - Surtex2025-02-07 Surtex Stainless Steel Post Dispenser Intro Kit - 18 Posts/Kit plus Accessories - Sizes: Short #1 and #2, Medium #1, #4, #5 and
07350081495602 - Surtex2025-02-07 Surtex Titanium Post Dispenser Intro Kit - 18 Posts/Kit plus Accessories - Post Material: Grade 1 Titanium - Sizes: Short #1 and
07350081490515 - Lamineer Tips2025-02-05 Spatula Lamineer Tips for Profin Reciprocating Contra-Angles - 2/Pack - Single Sided 100 Micron Diamond Coating
07350081490539 - Lamineer Tips2025-02-05 Spatula Lamineer Tips for Profin Reciprocating Contra-Angles - 2/Pack - Single Sided 15 Micron Diamond Coating
07350081490553 - Lamineer Tips2025-02-05 Spatula Lamineer Tips for Profin Reciprocating Contra-Angles - 2/Pack - Single Sided 150 Micron Diamond Coating
07350081490577 - Lamineer Tips2025-02-05 Spatula Lamineer Tips for Profin Reciprocating Contra-Angles - 2/Pack - Single Sided 30 Micron Diamond Coating
07350081490591 - Lamineer Tips2025-02-05 Spatula Lamineer Tips for Profin Reciprocating Contra-Angles - 2/Pack - Single Sided Wolfram Tungsten Coating

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.