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SMARTmatic PROPHY S19 1.011.6740

by KaVo Dental GmbH

Part of a family of 68 devices: see the family page

Ref 1.011.6740

SMARTmatic PROPHY S19 1.011.6740 is a device classified as Class IIa in the EU and Class I in the US made by KaVo Dental GmbH, registered in EUDAMED on 26 Jun 2026 (Basic UDI-DI ++EKAVG502Z5) with CE/MDR certificate 51512-60-01-00 valid until 28 Sep 2031, cleared under FDA 510(k) K163239 on 17 Mar 2017 and listed in FDA GUDID since 1 Mar 2021 (UDI-DI EKAV101167400), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

28 Sep 2031

CE MDR certificate

FDA recalls

None found

in data synced 22 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification GmbH

510(k) K163239

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number51512-60-01-00 Date1 Sep 2026IssuedStatusActive expires 28 Sep 2031
United StatesGUDID listing GUDID NumberEKAV101167400 UDI-DI Date1 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163239 Date17 Mar 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++EKAVG502Z5 registered 26 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K163239 decided 17 Mar 2017 Active
  • FDA GUDID UDI-DI EKAV101167400 listed 1 Mar 2021 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 51512-60-01-00 Active Reissued

    Quality management system EU MDR

    Certifier
    DEKRA Certification GmbH 0124
    Issued
    1 Sep 2026
    Expires
    28 Sep 2031
    Valid from
    29 Sep 2026

Timeline

5 dated events

  1. Cleared FDA 510(k) K163239
  2. Listed FDA GUDID EKAV101167400
  3. Registered EUDAMED ++EKAVG502Z5
  4. Certificate issued EUDAMED 51512-60-01-00
  5. Certificate expires EUDAMED 51512-60-01-00

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  • Withdrawn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
SMARTmatic PROPHY S19
Generic name
Dental power tool system handpiece, line-powered
Device name
Dental straight and contra-angle handpieces
Model / Ref / Catalog
1.011.6740, S19
Primary DI / UDI-DI
EKAV101167400
Basic UDI-DI
++EKAVG502Z5
510(k) Number
FDA product code
EFA
EMDN code
Z12110102 Dental drills
GMDN term
Dental power tool system handpiece, line-powered
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4200
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

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

Related devices

Category: Dental power tool system handpiece, line-powered

Cleared under the same submission (K163239)

and 8 more cleared under K163239

Similar devices in this category

Other devices filed under DENTAL DRILLS.

Other devices from KaVo Dental GmbH

See all devices from KaVo Dental GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)