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Dentitude LT-A3.5/L-18-15-13

by Fuzhou Rick Brown Biomaterials Co. Ltd.

Ref 0401012Model HT-A1, HT-A2, HT-A3, MT-A1, MT-A2, MT-A3, MT-B1, MT-B2, MT-C1, MT-C2, MT-BL1, MT-BL2, MT-BL3, MT-BL4, LT-A1, LT-A2, LT-A3, LT-A3.5, LT-A4, LT-B1, LT-B2, LT-B3, LT-C1, LT-C2, LT-C3, LT-D2, LT-D3, LT-BL1, LT-BL2, LT-BL3, LT-BL4, MO0, MO1,

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697614641DLDGC01NX Basic UDI-DI 06976146410437UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06976146410437 UDI-DI Date22 Mar 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Dentitude
Generic Name
Dental appliance fabrication material, ceramic
Device Name
Dental Lithium Disilicate Glass-Ceramic
Model / Reference
HT-A1 EUDAMED
HT-A2 EUDAMED
HT-A3 EUDAMED
MT-A1 EUDAMED
MT-A2 EUDAMED
MT-A3 EUDAMED
MT-B1 EUDAMED
MT-B2 EUDAMED
MT-C1 EUDAMED
MT-C2 EUDAMED
MT-BL1 EUDAMED
MT-BL2 EUDAMED
MT-BL3 EUDAMED
MT-BL4 EUDAMED
LT-A1 EUDAMED
LT-A2 EUDAMED
LT-A3 EUDAMED
LT-A3.5 EUDAMED
LT-A4 EUDAMED
LT-B1 EUDAMED
LT-B2 EUDAMED
LT-B3 EUDAMED
LT-C1 EUDAMED
LT-C2 EUDAMED
LT-C3 EUDAMED
LT-D2 EUDAMED
LT-D3 EUDAMED
LT-BL1 EUDAMED
LT-BL2 EUDAMED
LT-BL3 EUDAMED
LT-BL4 EUDAMED
MO0 EUDAMED
MO1 EUDAMED
0401012 EUDAMED
LT-A3.5/L-18-15-13 GUDID
Primary DI / UDI-DI
06976146410437
Basic UDI-DI
697614641DLDGC01NX
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 market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Dental appliance fabrication material, ceramic

Cleared under the same submission (K230487)

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Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No