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GingivalMarginTrimmer1.2mm, dis DTS

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 121-122ESTModel Dental hand instrument, gingival margin for the finishing of cavity

by LM-Instruments Oy

Identity

Trade Name
GingivalMarginTrimmer1.2mm,dis DTS EUDAMED
GingivalMarginTrimmer1.2mm,disDTS EUDAMED
LMDental FDA UDI
Generic Name
Dental excavator, reusable FDA UDI
Device Name
Restorative hand instrument Ir EUDAMED
Gingival Margin Trimmer, 1.2mm, distal DTS, Restoration FDA UDI
Model / Reference
Dental hand instrument, gingival margin for the finishing of cavity EUDAMED
121-122EST EUDAMEDFDA UDI
Description
Gingival Margin Trimmer, 1.2mm, distal DTS, Restoration FDA UDI

Identifiers

Primary DI / UDI-DI
06438311031217 EUDAMEDFDA UDI
Basic UDI-DI
B-06438311031217 EUDAMED
6438311RESTO1r0C6 EUDAMED
Direct Marketing DI
06438311031217 EUDAMED
FDA Product Code
DZN FDA UDI
EMDN Code
L159002 DENTAL EXCAVATORS, REUSABLE EUDAMED
GMDN Term
Dental excavator, 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

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

The GingivalMarginTrimmer1.2mm, dis DTS is a dental hand instrument designed for the finishing of cavity margins in dentistry. This device provides precise trimming and shaping of gingival tissue, making it an essential tool for various dental procedures.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

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

Sources (3)

  • EUDAMED 8f966b6d-da66-4faf-bf9e-fa953ec6144c 61 fields · synced Jul 19, 2026
  • EUDAMED a3ea918a-9aa2-443f-a595-986991dc9d18 61 fields · synced May 18, 2026
  • FDA UDI 04eaa8f4-e4bf-4652-b9f7-4bcbcb52f736 33 fields · synced May 30, 2026