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Diamond D 1013040

by Keystone Industries

Ref 1013040

Diamond D 1013040 is a device classified as Class IIa in the EU and Class II in the US made by Keystone Industries, registered in EUDAMED on 6 Apr 2026 (Basic UDI-DI B-++H66810130401), cleared under FDA 510(k) K032773 on 23 Sep 2003 and listed in FDA GUDID since 15 Sep 2016 (UDI-DI ++H66810130401), active as of 23 Oct 2026.

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

CE MDD 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 linked in EUDAMED

A group certificate may exist

510(k) K032773

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-++H66810130401 Basic UDI-DI ++H66810130401UDI-DIDate6 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number++H66810130401 UDI-DI Date15 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK032773 Date23 Sep 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-++H66810130401 registered 6 Apr 2026 Active
  • FDA 510(k) K032773 decided 23 Sep 2003 Active
  • FDA GUDID UDI-DI ++H66810130401 listed 15 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K032773
  2. Listed FDA GUDID ++H66810130401
  3. Registered EUDAMED B-++H66810130401

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Diamond D Ultra Impact Denture Acrylic EUDAMED
Diamond D GUDID
Generic name
Dental appliance fabrication material, resin
Device name
Dental Acrylic
Model / Ref / Catalog
1013040
Primary DI / UDI-DI
++H66810130401 EUDAMED
H66810130401 GUDID
Basic UDI-DI
B-++H66810130401
510(k) Number
FDA product code
EBI
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN term
Dental appliance fabrication material, resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3760
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Weight — 150 Gram

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
++H66810130401
GUDID
H66810130401
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists ++H66810130401; FDA GUDID lists H66810130401), 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: Dental appliance fabrication material, resin

Cleared under the same submission (K032773)

and 8 more cleared under K032773

Similar devices in this category

Other devices filed under MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER.

Other devices from Keystone Industries

See all devices from Keystone Industries →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)