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Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

FDA UDIFDA 510(k)EUDAMED

Class II (US FDA UDI)

510(k) K221051

by Changsha Honchon Technology Co., LTD

Identity

Trade Name
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank FDA UDI
Generic Name
Dental appliance fabrication material, combination-material FDA UDI
Model / Reference
4D-ML FDA UDI

Identifiers

Primary DI / UDI-DI
06977274260178 FDA UDI
510(k) Number
K221051 FDA UDI
FDA Product Code
EIH FDA UDI
GMDN Term
Dental appliance fabrication material, combination-material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.6660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Dental appliance fabrication material, combination-material

Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank by Changsha Honchon Technology Co., LTD — Class II — FDA_510K, MDR — listed in FDA GUDID, FDA 510(k)…

Similar devices

Also classified as Dental appliance fabrication material, combination-material.

Cleared under the same submission

K221051 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Unknown

MDR

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Manufacturer

Manufacturer
Changsha Honchon Technology Co., LTD
FDA Applicant
Changsha Honchon Technology Co., Ltd.

Sources (3)

  • FDA UDI 9418d4e7-75f7-4128-ab87-32aeeaa1f186 57 fields · synced Jun 20, 2026
  • FDA 510(k) K221051 1 fields · synced Jun 5, 2026
  • EUDAMED 1 fields · synced Jun 2, 2026