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Dental Ceramic

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 01Ref 06936536129547Model Metal Ceramic, Zirconia Ceramic, and associated accessory (Formative Liquid)Ref 06936536136361Ref 06936536120063Ref 06936536114567Ref 06936536110675Ref 06973133317786Ref 06936536120612Ref 06936536129127Ref 06936536136293Ref 06936536118855Ref 06936536140450Ref 06973133313474Ref 06973133314679Ref 06936536135869Ref 06936536124122Ref 06936536112280Ref 06936536140979Ref 06936536110736Ref 06973133311487Ref 06936536121794Ref 06936536137207Ref 06936536114376Ref 06973133319223Ref 06936536119388Ref 06936536117384Ref 06973133317526Ref 06936536127901Ref 06936536136156Ref 06936536141228Ref 06936536137832Ref 06973133317564Ref 06936536117933Ref 06936536112198Ref 06936536129448Ref 06936536139386Ref 06936536140313Ref 06936536142300Ref 06936536133315Ref 06936536114802Ref 06936536135265Ref 06936536117124Ref 06936536127987Ref 06936536126638Ref 06973133313016Ref 06936536113331Ref 06936536117094Ref 06936536113546Ref 06936536131274Ref 06936536140375Ref 06973133315171Ref 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by BAOT Biological Technology Co., Ltd.

Identity

Trade Name
Dental Ceramic EUDAMED
JC Metal Porcelain FDA UDI
ZCG Metal Procelain FDA UDI
BAOT FDA UDI
ZCG ZR Procelain FDA UDI
BAOT® FDA UDI
Generic Name
Dental appliance fabrication material, ceramic FDA UDI
Device Name
Dental Ceramic EUDAMED
Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers. FDA UDI
It is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers. FDA UDI
eneers and for zirconia full veneers and partial veneers. FDA UDI
Model / Reference
01 EUDAMED
Metal Ceramic, Zirconia Ceramic, and associated accessory (Formative Liquid) EUDAMED
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Dentine A4 FDA UDI
Dentine A2 FDA UDI
Enamel E-1B FDA UDI
GY 50ml FDA UDI
ZCG 5M1 15g FDA UDI
JC OP B2 15g FDA UDI
CFS 50ml FDA UDI
JC OP B1 5g FDA UDI
JC S-1D 3g FDA UDI
ZCG B2R1.5 15g FDA UDI
ZCG T-2B 15g FDA UDI
JC OP B2R2.5 5g FDA UDI
Dentine A1 FDA UDI
JC B3R1.5 50g FDA UDI
ZCG E-2B 50g FDA UDI
JC A4 15g FDA UDI
JC B3 15g FDA UDI
JC OP B3R1.5 5g FDA UDI
ZCG S-2B 3g FDA UDI
JC C-1C 15g FDA UDI
ZCG Transparent T-2A FDA UDI
ZCG 4M3 15g FDA UDI
Enamel E-2C FDA UDI
ZCG B1M1 50g FDA UDI
ZCG 3M1 15g FDA UDI
JC C3 15g FDA UDI
JC OP B1M1 5g FDA UDI
JC OD A3 15g FDA UDI
JC OP C2 15g FDA UDI
JC C-1A 15g FDA UDI
ZCG S-2A 3g FDA UDI
JC OD D3 15g FDA UDI
ZCG 3L2.5 15g FDA UDI
JC S-1A 3g FDA UDI
JC OP D3 15g FDA UDI
JC Transparent T-1B 15g FDA UDI
Formative liquid CFS 240ml FDA UDI
OD A4 15g FDA UDI
ZCG 5M3 15g FDA UDI
Dentine C2 FDA UDI
Glaze G-1 FDA UDI
JC Semi-transparent Enamel Effect EE-1B FDA UDI
JC B4 50g FDA UDI
ZCG 4L2.5 15g FDA UDI
JC Dentine OD A2 50g FDA UDI
JC OD C4 50g FDA UDI
JC OP B2M3 5g FDA UDI
JC B2M1 15g FDA UDI
ZCG 4R1.5 15g FDA UDI
JC B3M1 15g FDA UDI
JC B2R2.5 50g FDA UDI
ZCG B4 15g FDA UDI
JC M-1A 15g FDA UDI
JC D3 15g FDA UDI
JC Dentine C3 50g FDA UDI
JC Transparent T-1A FDA UDI
JC OP C1 15g FDA UDI
ZCG 2M2 15g FDA UDI
JC OP A3 15g FDA UDI
ZCG Semi-transparent Enamel Effect EE-2A FDA UDI
JC OP B2L1.5 5g FDA UDI
ZCG B3 50g FDA UDI
JC B2L1.5 15g FDA UDI
ZCG C4 15g FDA UDI
JC Opaque B1 50g FDA UDI
JC OD B2M1 50g FDA UDI
Dentine A3.5 FDA UDI
ZCG Dentine B2 FDA UDI
JC Dentine A3 FDA UDI
JC B4 15g FDA UDI
ZCG D4 15g FDA UDI
ZCG 3M2 15g FDA UDI
JC Semi-transparent Enamel Effect EE-1D FDA UDI
JC OP B3M3 15g FDA UDI
JC Semi-transparent Enamel Effect EE-1F FDA UDI
JC OP D3 5g FDA UDI
Dentine D2 FDA UDI
JC B1 50g FDA UDI
ZCG C3 50g FDA UDI
OF 50ml FDA UDI
Dentine B1M1 FDA UDI
ZCG A1 50g FDA UDI
JC Transparent T-1B 50g FDA UDI
JC OD B3 15g FDA UDI
ZCG B2L1.5 15g FDA UDI
ZCG D3 50g FDA UDI
JC OD B4 15g FDA UDI
JC D3 50g FDA UDI
OD A3.5 15g FDA UDI
ZCG C3 15g FDA UDI
JC OP A3.5 15g FDA UDI
ZCG D2 50g FDA UDI
JC OP B1 15g FDA UDI
ZCG Transparent Gingiva GIN-2A FDA UDI
JC C4 50g FDA UDI
OD D2 15g FDA UDI
G-1 5g FDA UDI
ZCG T-2B 50g FDA UDI
JC Dentine OD B1 50g FDA UDI
JC OD C1 15g FDA UDI
ZCG A3 50g FDA UDI
Enamel E-2A FDA UDI
JC M-1B 15g FDA UDI
ZCG B3 15g FDA UDI
ZCG S-2C 3g FDA UDI
JC Dentine A3 50g FDA UDI
JC C-1D 15g FDA UDI
JC Semi-transparent Enamel Effect EE-1A FDA UDI
ZCG B2M2 50g FDA UDI
JC D4 15g FDA UDI
JC OP B3 5g FDA UDI
JC Dentine B3 50g FDA UDI
ZCG C4 50g FDA UDI
JC B1M1 50g FDA UDI
G-2 5g FDA UDI
JC Semi-transparent Enamel E-1B 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
It is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers. FDA UDI
eneers and for zirconia full veneers and partial veneers. FDA UDI

Identifiers

Primary DI / UDI-DI
06973133310657 EUDAMEDFDA UDI
06973133310046 EUDAMEDFDA UDI
06973133310183 EUDAMEDFDA UDI
06973133310091 EUDAMEDFDA UDI
06973133310954 EUDAMEDFDA UDI
06973133312439 EUDAMEDFDA UDI
06973133312019 EUDAMEDFDA UDI
06973133311944 EUDAMEDFDA UDI
06973133311197 EUDAMEDFDA UDI
06973133310763 EUDAMEDFDA UDI
06973133310879 EUDAMEDFDA UDI
06973133311968 EUDAMEDFDA UDI
06973133311005 EUDAMEDFDA UDI
06973133310121 EUDAMEDFDA UDI
06973133310015 EUDAMEDFDA UDI
06973133311241 EUDAMEDFDA UDI
06973133310923 EUDAMEDFDA UDI
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Basic UDI-DI
B-06973133310657 EUDAMED
697313331CE01BG EUDAMED
510(k) Number
K182350 FDA UDI
FDA Product Code
EIH FDA UDI
EMDN Code
Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
GMDN Term
Dental appliance fabrication material, ceramic FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.6660 FDA UDI
Market of Registration
Poland EUDAMED
Türkiye EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDIEUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDIFDA 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 UDIFDA 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 UDIFDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, ceramic

Dental Ceramic by BAOT Biological Technology Co., Ltd. — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, ceramic.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

European Union Active

CE/MDD

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
BAOT Biological Technology Co., Ltd.
EUDAMED SRN
CN-MF-000017164
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2444)

  • EUDAMED 118e0100-129f-4bb3-a369-d9ea4e336abc 61 fields · synced Oct 1, 2026
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