DEVICE: Profin with IPR Lamineer Tips (07350081496746)
Device Identifier (DI) Information
Profin with IPR Lamineer Tips
PDX-P/SK2
In Commercial Distribution
PDX-P/SK2
Dentatus AB
PDX-P/SK2
In Commercial Distribution
PDX-P/SK2
Dentatus AB
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
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
66245 | Dental surgical power tool motorized handpiece/set, electric |
An electrically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade] for drilling, cutting, polishing, and/or inserting procedures involving bones and tough tissues during a dental surgical procedure. It includes an electric motor and the appropriate attachments (e.g., angle adaptor, torque multiplier) at its distal end for connection of the endpieces and may include a rechargeable battery or a control unit; the endpieces are not included. This is a reusable device.
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Active | false |
44730 | Interproximal reduction kit |
A collection of devices intended to be used for interproximal reduction (IPR), which is the reduction of contact between adjacent teeth during orthodontic alignment of the teeth. Fine abrasives are typically used to minimize pressure and allow the formation of spaces between the teeth, enabling more effective therapy without excessive interproximal contact, which may prolong or complicate teeth alignment. The device may include burs, abrasive disks, abrasive strips, thickness gauges and charts for tracking of reproximation. This device is reusable, but certain items will need to be replenished.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EHL | Point, Abrasive |
EGS | Handpiece, Contra- And Right-Angle Attachment, Dental |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b977d07c-7889-48b3-9c80-7eee16a67cfd
November 01, 2024
1
October 24, 2024
November 01, 2024
1
October 24, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined