Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8032033

FEI Number

3343

Entity Name

LM-INSTRUMENTS OY

City/State/Country

PARAINEN Varsinais-Suomi, FI

Establishment Address

NORRBYN RANTATIE 8, PARAINEN Varsinais-Suomi 21600, FI

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LM-INSTRUMENTS OY (Owner Number: 8032033)

Owner / Operator Contact Address

PL 88 (NORRBYN RANTATIE 8), --, PARAINEN, FI-NOTA 21601, FI

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LM-DENTAL LM-LiftOut ErgoAccess LM-TwistOut ErgoMix SoftGrip LM-RootOut LM-SlimLift LMServo5 LMServoMax LMServoMax tray system LMServo LMServo8 LMServo8E LMServo5E LMErgoHold3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2003-04-14
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2015-06-16
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2013-12-12
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2013-12-12
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2015-06-16

Official Correspondent

Mia Weckmann-Kesti

US Agent Details

Anssi DuMontier Email: anssi.dumontier@lm-dental.com Phone: (406) 2400026

Related Public Records

Same Entity

LM-INSTRUMENTS OY

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2016	Zimmer, Inc.	1	Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

Similar Registrations

Registration Number	Establishment Name	Location
3016954909	IMPLANT PROTESIS DENTAL 2004, S.L.	Premia de Dalt Barcelona, ES
3005972890	GoldenDent	Roseville, MI, US
3008808049	SURGICRAFTS	Sialkot Punjab, PK
3010583458	ZOGEAR Medical Co., Ltd.	Yizheng Jiangsu, CN
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8032033. Last updated year: 2026. Please use registration number 8032033 when referencing this establishment in official correspondence.