Dental Porcelain Powder

FDA UDIEUDAMED

Class II (US FDA UDI)

by Chengdu Besmile Medical Technology Co., Ltd.

Identity

Trade Name: Dental Porcelain Powder FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Model / Reference: Stain/Glaze BS C5 20g FDA UDI

Identifiers

Primary DI / UDI-DI: 06932195340118 FDA UDI
510(k) Number: K232676 FDA UDI
FDA Product Code: EIH FDA UDI
GMDN Term: Dental appliance fabrication material, ceramic 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, ceramic

Dental Porcelain Powder by Chengdu Besmile Medical Technology Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Chengdu Besmile Medical Technology Co., Ltd.

Sources (2)

FDA UDI 6306f5e5-aa12-4f82-b067-1eee4640a82d 33 fields · synced Oct 7, 2026
EUDAMED 1 fields · synced Jun 1, 2026