Multiholder PK III Gengiva DTS

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 752-756EST

by LM-Instruments Oy

Identity

Trade Name: Multiholder PK III Gengiva DTS EUDAMED
LMDental FDA UDI
Generic Name: Manual dental burnisher, reusable FDA UDI
Device Name: Restorative dental hand instrument EUDAMED
Multiholder PK III, Gengiva DTS, Restoration FDA UDI
Model / Reference: 752-756EST EUDAMEDFDA UDI
Description: Multiholder PK III, Gengiva DTS, Restoration FDA UDI

Identifiers

Primary DI / UDI-DI: 06438311036441 EUDAMEDFDA UDI
Basic UDI-DI: 6438311RESTO102Y EUDAMED
Direct Marketing DI: 06438311036441 EUDAMED
FDA Product Code: DZN FDA UDI
EMDN Code: Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
GMDN Term: Manual dental burnisher, reusable FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.4565 FDA UDI
Market of Registration: Finland EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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: Dental appliance fabrication material, ceramic

Multiholder PK III Gengiva DTS by LM-Instruments Oy — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/MDR	6438311RESTO102Y	Class I	Active
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: LM-Instruments Oy
EUDAMED SRN: FI-MF-000006705

Sources (2)

EUDAMED 96165849-665a-43f7-9317-7374acec0fec 61 fields · synced Jun 18, 2026
FDA UDI 669c425a-7d11-413f-b92a-6be6c1572f2d 33 fields · synced May 30, 2026