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Planmeca SingLED

by Planmeca Oy

Ref 10020815

Planmeca SingLED (10020815) is a Class I device made by Planmeca Oy, registered in EUDAMED on 25 Oct 2021 (Basic UDI-DI 6430035420045K), cleared under FDA 510(k) K923462 on 21 Dec 1992 and listed in FDA GUDID since 5 May 2017 (UDI-DI 06430035420247), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K923462

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number6430035420045K Basic UDI-DI 06430035420247UDI-DIDate25 Oct 2021RegisteredStatusActive
United StatesGUDID listing GUDID Number06430035420247 UDI-DI Date5 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK923462 Date21 Dec 1992DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 6430035420045K registered 25 Oct 2021 Active
  • FDA 510(k) K923462 decided 21 Dec 1992 Active
  • FDA GUDID UDI-DI 06430035420247 listed 5 May 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K923462
  2. Listed FDA GUDID 06430035420247
  3. Registered EUDAMED 6430035420045K

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
LED dental light, line-powered
Model / Ref / Catalog
10020815, SingLED
Primary DI / UDI-DI
06430035420247
Basic UDI-DI
6430035420045K
510(k) Number
FDA product code
EAZ
EMDN code
Z12110180 Instruments for dental treatment units - hardware accessories
GMDN term
LED dental light, line-powered
Device class
Class I
Regulation number
872.4630
EU registration type
Standard device
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
10020815
GUDID
SingLED

Manufacturer details

EUDAMED SRN
FI-MF-000006499

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES.

Other devices from Planmeca Oy

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Properties

  • Serial number
  • Manufacturing date
Other properties (23, all answered No)