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Amber® Mill Amber MIll C14/A4

by Hass Corporation

Ref Mill C14/A4Model Amber

Amber® Mill Amber MIll C14/A4 is a device classified as Class IIa in the EU and Class II in the US made by Hass Corporation, registered in EUDAMED on 19 Oct 2026 (Basic UDI-DI B-08800057160908), cleared under FDA 510(k) K160102 on 14 Jul 2016 and listed in FDA GUDID since 1 May 2024 (UDI-DI 08800057160908), 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) K160102

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-08800057160908 Basic UDI-DI 08800057160908UDI-DIDate19 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800057160908 UDI-DI Date1 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160102 Date14 Jul 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08800057160908 registered 19 Oct 2026 Active
  • FDA 510(k) K160102 decided 14 Jul 2016 Active
  • FDA GUDID UDI-DI 08800057160908 listed 1 May 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160102
  2. Listed FDA GUDID 08800057160908
  3. Registered EUDAMED B-08800057160908

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  • Withdrawn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
Amber Mill C14/A4 EUDAMED
Amber® Mill GUDID
Generic name
Dental appliance fabrication material, ceramic
Model / reference
Amber EUDAMED
Mill C14/A4 EUDAMED
Amber MIll C14/A4 GUDID
Primary DI / UDI-DI
08800057160908
Basic UDI-DI
B-08800057160908
510(k) Number
FDA product code
EIH
EMDN code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN term
Dental appliance fabrication material, ceramic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.6660
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Amber
Mill C14/A4
GUDID
Amber MIll C14/A4
Device classEUDAMED
Class IIa
GUDID
Class II

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, ceramic

Cleared under the same submission (K160102)

and 8 more cleared under K160102

Similar devices in this category

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

Other devices from Hass Corporation

See all devices from Hass Corporation →

Properties

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