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LM-Syntette, Mini SD

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 215-216MSDESModel Dental hand instrument, curette for the removal of the subgingival and supragingival calculus

by LM-Instruments Oy

Identity

Trade Name
LM-Syntette, Mini SD EUDAMED
LMDental FDA UDI
Generic Name
Periodontal curette FDA UDI
Device Name
Periodontal hand instrument EUDAMED
LM-Syntette, Mini SD, Curette, Periodontics FDA UDI
Model / Reference
215-216MSDES EUDAMEDFDA UDI
Dental hand instrument, curette for the removal of the subgingival and supragingival calculus EUDAMED
Description
LM-Syntette, Mini SD, Curette, Periodontics FDA UDI

Identifiers

Primary DI / UDI-DI
06438311208800 EUDAMEDFDA UDI
Basic UDI-DI
6438311PERIO1r06S EUDAMED
B-06438311208800 EUDAMED
Direct Marketing DI
06438311208800 EUDAMED
FDA Product Code
DZN FDA UDI
EMDN Code
L159001 DENTAL AND PERIODONTAL CURETTES, REUSABLE EUDAMED
GMDN Term
Periodontal curette 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

LM-Syntette, Mini SD by LM-Instruments Oy — Class I — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

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

Sources (3)

  • EUDAMED ced5b703-80fb-4d84-a4a4-3879899c2afc 61 fields · synced Jul 18, 2026
  • EUDAMED 519564e9-3cce-4061-9c34-2cd7a825de4a 61 fields · synced May 19, 2026
  • FDA UDI 9c5a5753-78c2-4484-a6b7-090b01eaf9fc 33 fields · synced May 29, 2026