Metal Procelain

FDA UDI

Class II (US FDA UDI)

by BAOT Biological Technology Co., Ltd.

Identity

Trade Name: Metal Procelain FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: It is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers. FDA UDI
Model / Reference: Standard Kit FDA UDI
Description: It is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers. FDA UDI

Identifiers

Primary DI / UDI-DI: 06973133310190 FDA UDI
510(k) Number: K182350 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

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, ceramic

Metal Procelain by BAOT Biological Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: BAOT Biological Technology Co., Ltd.

Sources (1)

FDA UDI 36c3f54f-2b94-401d-9745-be53bfe5079b 34 fields · synced May 30, 2026