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StoneBite® D504872

by Dreve Dentamid GmbH

Part of a family of 9 devices: see the family page

Ref D504872

StoneBite® D504872 is a device classified as Class IIa in the EU and Class II in the US made by Dreve Dentamid GmbH, registered in EUDAMED on 18 May 2026 (Basic UDI-DI ++E2390017Y7), cleared under FDA 510(k) K190571 on 7 Nov 2019 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI +E239D5048721), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190571

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E2390017Y7 Basic UDI-DI +E239D5048721UDI-DIDate18 May 2026RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK190571 Date7 Nov 2019DecidedStatusActive
United StatesGUDID listing GUDID Number+E239D5048721 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++E2390017Y7 registered 18 May 2026 Active
  • FDA 510(k) K190571 decided 7 Nov 2019 Active
  • FDA GUDID UDI-DI +E239D5048721 listed 22 Sep 2016 Listed

Timeline

3 dated events

  1. Listed FDA GUDID +E239D5048721
  2. Cleared FDA 510(k) K190571
  3. Registered EUDAMED ++E2390017Y7

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  • Withdrawn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
StoneBite®
Generic name
Bite registration rim wax
Device name
Bissregistriermaterial auf Vinylpolysiloxanbasis
Model / Ref / Catalog
D504872
Primary DI / UDI-DI
+E239D5048721 EUDAMED
E239D5048721 GUDID
Basic UDI-DI
++E2390017Y7
510(k) Number
FDA product code
ELW
EMDN code
Q01020102 Dental impression vinylsiloxans
GMDN term
Bite registration rim wax
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3660
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+E239D5048721
GUDID
E239D5048721
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E239D5048721; FDA GUDID lists E239D5048721), so their flags are not compared. 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: Bite registration rim wax

Cleared under the same submission (K190571)

Similar devices in this category

Other devices filed under DENTAL IMPRESSION VINYLSILOXANS.

Other devices from Dreve Dentamid GmbH

See all devices from Dreve Dentamid GmbH →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)