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Profisil Free Unflavored Sample pack

by Kettenbach GmbH & Co. KG

Ref 14839Model Profisil Free

Profisil Free Unflavored Sample pack (14839) is a device classified as Class I in the EU and Class II in the US made by Kettenbach GmbH & Co. KG, cleared under FDA 510(k) K262243 on 3 Sep 2026, registered in EUDAMED on 20 Jul 2026 (Basic UDI-DI ++E217PROFREE65) and listed in FDA GUDID since 10 Sep 2026 (UDI-DI E217148391), active as of 23 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 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K262243

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberE217148391 UDI-DI Date10 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK262243 Date3 Sep 2026DecidedStatusActive
European UnionCE/MDR EUDAMED Number++E217PROFREE65 Basic UDI-DI E217148391UDI-DIDate20 Jul 2026RegisteredStatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K262243 decided 3 Sep 2026 Active
  • EUDAMED Basic UDI-DI ++E217PROFREE65 registered 20 Jul 2026 Active
  • FDA GUDID UDI-DI E217148391 listed 10 Sep 2026 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. Registered EUDAMED ++E217PROFREE65
  2. Cleared FDA 510(k) K262243
  3. Listed FDA GUDID E217148391

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  • Withdrawn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 Free Unflavored Sample pack EUDAMED
Profisil GUDID
Generic name
Dental coating, tooth-desensitizing, professional
Device name
Profisil Free
Model / reference
Profisil Free, 14839
Primary DI / UDI-DI
E217148391
Basic UDI-DI
++E217PROFREE65
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.

Manufacturer details

EUDAMED SRN
DE-MF-000005014

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)