← Back to catalogue

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

EUDAMEDFDA 510(k)FDA UDI

Class IIa (EU MDR)

Ref SHT-CModel HT-Plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, UT, UT-C, UT-ML, 3D-Pro-ML510(k) K221242

by Hunan Vsmile Biotechnology Co., Ltd

Identity

Trade Name
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank EUDAMED
Vsmilehappyzir Dental Zirconia Blank &Dental Zirconia Pre-Shaded Blank FDA UDI
Generic Name
Dental appliance fabrication material, combination-material FDA UDI
Device Name
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank EUDAMED
Model / Reference
HT-Plus, ST, ST-C, ST-ML, SHT, SHT-C, SHT-ML, UT, UT-C, UT-ML, 3D-Pro-ML EUDAMED
SHT-C EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
06974668761495 EUDAMEDFDA UDI
Basic UDI-DI
697466876001QZ EUDAMED
Direct Marketing DI
06974668761495 EUDAMED
510(k) Number
K221242 FDA 510(k)FDA UDI
FDA Product Code
EIH FDA 510(k)FDA UDI
EMDN Code
Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
GMDN Term
Dental appliance fabrication material, combination-material FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.6660 FDA 510(k)
Regulation Number
872.6660 FDA 510(k)FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank by Hunan Vsmile Biotechnology Co., Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)…

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Hunan Vsmile Biotechnology Co., Ltd
EUDAMED SRN
CN-MF-000051840
FDA Applicant
Hunan Vsmile Biotechnology Co., Ltd.
Authorised Representative
Eunitor GmbH DE-AR-000005081

Sources (3)

  • EUDAMED 6356a288-89e4-4891-967c-cbce39562465 85 fields · synced Jun 18, 2026
  • FDA 510(k) K221242 24 fields · synced May 18, 2026
  • FDA UDI 81602755-987d-4f3b-a445-2a6ff1deccf3 33 fields · synced May 26, 2026