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Filling Remover DTS

by LM-Instruments Oy

Ref 764-766EST

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6438311RESTO102Y Basic UDI-DI 06438311037646UDI-DIDate5 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number06438311037646 UDI-DI Date31 Aug 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Filling Remover DTS EUDAMED
LMDental GUDID
Generic Name
Dental restoration carver, resin
Device Name
Restorative dental hand instrument
Model / Reference
764-766EST
Primary DI / UDI-DI
06438311037646
Basic UDI-DI
6438311RESTO102Y
Direct Marketing DI
06438311037646
FDA Product Code
DZN
EMDN Code
Q01010199 Dental restoration devices - other
GMDN Term
Dental restoration carver, resin
Device Class
Class I
Regulation Number
872.4565
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
FI-MF-000006705

Other devices from LM-Instruments Oy

See all devices from LM-Instruments Oy →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No