FDA.reportPublic FDA data

BAOT®

Primary DI
06936536149873
Brand
BAOT®
Company
BAOT Biological Technology Co., Ltd.
Model
ZCG B0M2 50g
Device description
Dental Ceramic is indicated for use for metal-ceramic full veneers and partial veneers and for zirconia full veneers and partial veneers.
Published
2026-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182350000Dental CeramicBaot Biological Technology Co., Ltd.2019-05-22EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936536149873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936536149873069365361498736936536149873

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Regulatory Flags#

DUNS number
560453518
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936536143772BAOT®Zirconia Ceramic,Dentine,B0M32026-04-20
06973133314235BAOT®JC Opaque B1 50g2024-08-21
06973133314280BAOT®JC Opaque A3 50g2024-08-20
06973133313726BAOT®OP B0M2 5g2023-07-29
06973133312583BAOTJC OP A2 50g2023-06-30
06973133312392BAOTJC OP B3M3 15g2022-07-14
06973133312408BAOTJC OD D3 15g2022-07-14
06973133312415BAOTZCG 5M3 15g2022-07-14
06973133312422BAOTZCG 5M2 15g2022-07-14
06973133312439BAOTZCG 5M1 15g2022-07-14
06973133312446BAOTZCG 4R2.5 15g2022-07-14
06973133312453BAOTZCG 4R1.5 15g2022-07-14
06973133312460BAOTZCG 4M3 15g2022-07-14
06973133312477BAOTZCG 4M2 15g2022-07-14
06973133312484BAOTZCG 4L2.5 15g2022-07-14
06973133312491BAOTZCG 3R2.5 15g2022-07-14
06973133312507BAOTZCG 3M3 15g2022-07-14
06973133312514BAOTZCG 3M2 15g2022-07-14
06973133312521BAOTZCG 3M1 15g2022-07-14
06973133312538BAOTZCG 3L2.5 15g2022-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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