FDA.report

Aidite

Primary DI
06976087534797
Brand
Aidite
Company
Aidite (Qinhuangdao) Technology Co., Ltd.
Model
Color
Published
2023-07-16
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

Related Records

Product Codes

CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06976087534797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06976087534797069760875347976976087534797

GMDN Terms

TermDefinition
Denture base resin kitA collection of resins and other devices and/or materials intended to be used in the dental laboratory to manufacture a complete or partial denture base (the portion of a denture that rests on the oral mucosa and retains the artificial teeth). It usually includes the resin monomer (e.g., acrylic monomer of methyl methacrylate), a catalyst intended for polymerization, and additional products such as pigments, plasticizers, and/or devices (e.g., flasks, clamps). This is a single-use device.

Sterilization Methods

Method

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 DIBrandModelCatalogPublished
06979046193189AiditeSHT-Plus2026-03-10
06977979289702CameoST2025-11-17
06977979289719CameoST2025-11-17
06977979289726CameoST2025-11-17
06977979289856AiditeAPMR022025-11-17
06978447932199Aidite PmmaMultilayer2025-11-17
06978447932427CameoST2025-11-17
06978447932434CameoST2025-11-17
06978447932441CameoST2025-11-17
06978447932458CameoST2025-11-17
06978447932465CameoST2025-11-17
06978447932496AiditeFDB-LM2025-11-17
06978447932519AiditeFDB-LM2025-11-17
06978447932526AiditeFDB-LM2025-11-17
06978447932533AiditeFDB-LM2025-11-17
06978447932618AiditeMonochromatic2025-11-17
06978447933196AiditeMonochromatic2025-11-17
06978447933219AiditeMonochromatic2025-11-17
06978447933264Aidite PmmaColor2025-11-17
06978447933707AiditeAidite2025-11-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08800055726946C&B 5.0 HybridARUM DENTISTRY Co., Ltd.EBG2026-03-10
08800055726953C&B 5.0 HybridARUM DENTISTRY Co., Ltd.EBG2026-03-10
06971437944158UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944165UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944172UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944189UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
06971437944196UltraPrint Temp C&B UVGUANGZHOU HEYGEARS IMC.INCEBG2026-03-04
E235DD18B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD20B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD25A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD30B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD35A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD35A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D18B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D20A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D20B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D25A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D25A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D30A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D30A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D30B1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D35A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235D35A2MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-02-02
E235DD18A1ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-01-25
E235DD18A1MN0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-01-25
E235DD18A2ML0DENTADISCSHOFU DENTAL CORPORATIONEBG2026-01-25