IPR Lamineer Tips

FDA UDI

Class I (US FDA UDI)

by Dentatus AB

Identity

Trade Name: IPR Lamineer Tips FDA UDI
Generic Name: Interproximal reduction kit FDA UDI
Device Name: 5x Assorted Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 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: LTA-P/SK2 FDA UDI
Description: 5x Assorted Inter-Proximal Reduction Lamineer Tips for Profin Reciprocating Contra-Angles 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: LTA-P/SK2 FDA UDI
Primary DI / UDI-DI: 07350081495640 FDA UDI
FDA Product Code: EGS FDA UDI
GMDN Term: Interproximal reduction kit FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Interproximal reduction kit

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 438f7224-70df-49ff-806f-02a9e8a7d04c 34 fields · synced Jun 1, 2026