Profin with IPR Lamineer Tips PDX-P/SK2

GUDID 07350081496746

Profin PDX Reciprocating Contra/Angle E-Type with 5x Assorted Inter-Proximal Reduction Lamineer Tips 1 of each of the following: 0.1mm Blade Thickness, Double Sided 15 Micron Diamond Coating 0.2mm Blade Thickness, Double Sided 40 Micron Diamond Coating 0.3mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.4mm Blade Thickness, Double Sided 50 Micron Diamond Coating 0.5mm Blade Thickness, Double Sided 50 Micron Diamond Coating

Dentatus AB

Dental surgical power tool motorized handpiece/set, electric
Primary Device ID07350081496746
NIH Device Record Keyb977d07c-7889-48b3-9c80-7eee16a67cfd
Commercial Distribution StatusIn Commercial Distribution
Brand NameProfin with IPR Lamineer Tips
Version Model NumberPDX-P/SK2
Catalog NumberPDX-P/SK2
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 Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107350081496746 [Primary]

FDA Product Code

EHLPoint, Abrasive

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

[07350081496746]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-01
Device Publish Date2024-10-24

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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