Baot

FDA UDI

Class II (US FDA UDI)

by BAOT Biological Technology Co., Ltd.

Identity

Trade Name: BAOT FDA UDI
Generic Name: Dental appliance fabrication material, ceramic FDA UDI
Device Name: Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers. FDA UDI
Model / Reference: ZCG B1 50g FDA UDI
Description: Dental Ceramic 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: 06973133310787 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

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

Similar devices

Also classified as Dental appliance fabrication material, ceramic.

Razor / MegaPlus — U&C International Co., Ltd · Class II
rainbow High shine — Genoss · Class II
Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
Multi M Series — DMAX Co., Ltd. · Class II
Multi M Series — DMAX Co., Ltd. · Class II
BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
CGI — CERAGROUP INDUSTRIES · Class II
ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II

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

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

Manufacturer

Manufacturer: BAOT Biological Technology Co., Ltd.

Sources (1)

FDA UDI c1a568d4-a585-4741-bf60-fc7c89c9f725 34 fields · synced Jun 8, 2026