FDA.reportPublic FDA data

Aidite

Primary DI
06979046196838
Brand
Aidite
Company
Aidite (Qinhuangdao) Technology Co., Ltd.
Model
MC
Published
2026-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
K250811000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250811000Dental Zirconia CeramicAidite (Qinhuangdao) Technology Co., Ltd.2025-04-11EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06979046196838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06979046196838069790461968386979046196838

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
529607549
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
06979046195251AiditeMC2026-08-27
06979046196036AiditeMC2026-08-27
06979046196234AiditeMC2026-08-27
06979046196333AiditeMC2026-08-27
06979046196364AiditeMC2026-08-27
06979046196401AiditeMC2026-08-27
06979046196463AiditeMC2026-08-27
06979046196470AiditeMC2026-08-27
06979046196753AiditeMC2026-08-27
06979046196821AiditeMC2026-08-27
06979046196845AiditeMC2026-08-27
06979046196852AiditeMC2026-08-27
06979046196869AiditeMC2026-08-27
06979046196913AiditeMC2026-08-27
06979046196920AiditeMC2026-08-27
06979046196937AiditeMC2026-08-27
06979046196951AiditeMC2026-08-27
06979046196968AiditeMC2026-08-27
06979046196975AiditeMC2026-08-27
06979046197002AiditeMC2026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979046195251AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196036AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196234AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196333AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196364AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196401AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196463AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196470AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196753AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196821AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196845AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196852AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196869AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196913AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196920AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196937AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196951AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196968AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046196975AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197002AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197019AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197026AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197033AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197057AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197064AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197255AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197279AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197491AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197620AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27
06979046197637AiditeAidite (Qinhuangdao) Technology Co., Ltd.EIH2026-08-27