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Shining 3D® Sh-40B

by Shining 3D Tech Co., Ltd.

Part of a family of 208 devices: see the family page

Ref 0080Model HACS-A15-1，HACS-A15-2，HACS-A15-3，HACS-A15-4，HACS-A15-5，HACS-A20-1，HACS-A20-2，HACS-A20-3，HACS-A20-4，HACS-A20-5，HACS-A25-1，HACS-A25-2，HACS-A25-3，HACS-A25-4，HACS-A25-5

Shining 3D® Sh-40B is a Class I device made by Shining 3D Tech Co., Ltd., registered in EUDAMED on 27 Jun 2024 (Basic UDI-DI 697016308ScanbodyNP) and listed in FDA GUDID since 13 Jul 2026 (UDI-DI 06942799000080), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06942799000080 UDI-DI Date13 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697016308ScanbodyNP Basic UDI-DI 06942799000080UDI-DIDate27 Jun 2024RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 697016308ScanbodyNP registered 27 Jun 2024 Active
  • FDA GUDID UDI-DI 06942799000080 listed 13 Jul 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 697016308ScanbodyNP
  2. Listed FDA GUDID 06942799000080

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Sh-40B EUDAMED
Shining 3D® GUDID
Generic name
Dental implant abutment analog, laboratory
Model / reference
HACS-A15-1，HACS-A15-2，HACS-A15-3，HACS-A15-4，HACS-A15-5，HACS-A20-1，HACS-A20-2，HACS-A20-3，HACS-A20-4，HACS-A20-5，HACS-A25-1，HACS-A25-2，HACS-A25-3，HACS-A25-4，HACS-A25-5 EUDAMED
0080 EUDAMED
SH-40B GUDID
Primary DI / UDI-DI
06942799000080
Basic UDI-DI
697016308ScanbodyNP
Direct marketing DI
06942799000080
FDA product code
NDP
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental implant abutment analog, laboratory
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Other devices filed under ODONTOLOGY DEVICES - OTHER.

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Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)