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Profisil 14821

by Kettenbach GmbH & Co. KG

Part of a family of 12 devices: see the family page

Ref 14821Model Profisil Fluoride Varnish Plus

Profisil 14821 is a device classified as Class I in the EU and Class II in the US made by Kettenbach GmbH & Co. KG, registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI ++E217PROFLUORIDPLUS8U), cleared under FDA 510(k) K230333 on 24 Jul 2023 and listed in FDA GUDID since 2 Apr 2025 (UDI-DI E217148211), 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, self-declared

Class I: no certifier involved

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++E217PROFLUORIDPLUS8U Basic UDI-DI E217148211UDI-DIDate20 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberE217148211 UDI-DI Date2 Apr 2025ListedStatusListed 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 ++E217PROFLUORIDPLUS8U registered 20 Jul 2026 Active
  • FDA 510(k) K230333 decided 24 Jul 2023 Active
  • FDA GUDID UDI-DI E217148211 listed 2 Apr 2025 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K230333
  2. Listed FDA GUDID E217148211
  3. Registered EUDAMED ++E217PROFLUORIDPLUS8U

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  • Withdrawn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 Fluoride Varnish Plus Combi pack EUDAMED
Profisil GUDID
Generic name
Dental coating, tooth-desensitizing, professional
Model / Ref / Catalog
14821, Profisil Fluoride Varnish Plus
Primary DI / UDI-DI
E217148211
Basic UDI-DI
++E217PROFLUORIDPLUS8U
510(k) Number
FDA product code
LBH
EMDN code
Q019008 Dentinal desensitisers
GMDN term
Dental coating, tooth-desensitizing, professional
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.3260
System or procedure pack
Procedure pack which is a device in itself
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 I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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)