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Profisil 14800

by Kettenbach GmbH & Co. KG

Part of a family of 11 devices: see the family page

Ref 14800Model Profisil Fluoride Varnish

Profisil 14800 is a device classified as Class IIa in the EU and Class II in the US made by Kettenbach GmbH & Co. KG, registered in EUDAMED on 10 Jun 2024 (Basic UDI-DI ++E217PROFLUORID5XY), cleared under FDA 510(k) K230333 on 24 Jul 2023 and listed in FDA GUDID since 1 Aug 2023 (UDI-DI E217148001), active as of 25 Oct 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230333

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E217PROFLUORID5XY Basic UDI-DI E217148001UDI-DIDate10 Jun 2024RegisteredStatusActive
United StatesGUDID listing GUDID NumberE217148001 UDI-DI Date1 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK230333 Date24 Jul 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++E217PROFLUORID5XY registered 10 Jun 2024 Active
  • FDA 510(k) K230333 decided 24 Jul 2023 Active
  • FDA GUDID UDI-DI E217148001 listed 1 Aug 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230333
  2. Listed FDA GUDID E217148001
  3. Registered EUDAMED ++E217PROFLUORID5XY

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  • Withdrawn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

Trade name
Profisil
Generic name
Dental coating, tooth-desensitizing, professional
Model / Ref / Catalog
14800, Profisil Fluoride Varnish
Primary DI / UDI-DI
E217148001
Basic UDI-DI
++E217PROFLUORID5XY
510(k) Number
FDA product code
LBH
EMDN code
Q019008 Dentinal desensitisers
GMDN term
Dental coating, tooth-desensitizing, professional
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3260
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental coating, tooth-desensitizing, professional

Cleared under the same submission (K230333)

and 7 more cleared under K230333

Similar devices in this category

Other devices filed under DENTINAL DESENSITISERS.

Other devices from Kettenbach GmbH & Co. KG

See all devices from Kettenbach GmbH & Co. KG →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)