Profin with IPR Lamineer Tips

FDA UDI

Class I (US FDA UDI)

by Dentatus AB

Identity

Trade Name: Profin with IPR Lamineer Tips FDA UDI
Generic Name: Dental surgical power tool motorized handpiece/set, electric FDA UDI
Device Name: 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 FDA UDI
Model / Reference: PDX-P/SK2 FDA UDI
Description: 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 FDA UDI

Identifiers

Catalog Number: PDX-P/SK2 FDA UDI
Primary DI / UDI-DI: 07350081496746 FDA UDI
FDA Product Code: EHL FDA UDI
EGS FDA UDI
GMDN Term: Dental surgical power tool motorized handpiece/set, electric FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6010 FDA UDI
872.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Dental surgical power tool motorized handpiece/set, electric Interproximal reduction kit

Profin with IPR Lamineer Tips by Dentatus AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Dentatus AB

Sources (1)

FDA UDI b977d07c-7889-48b3-9c80-7eee16a67cfd 34 fields · synced May 30, 2026