FDA.report

Dental Casting

Primary DI
06934906696972
Brand
Dental Casting
Company
Aidite (Qinhuangdao) Technology Co., Ltd.
Model
Aidite
Device description
Used to make oral soft and hard tissue male model or prosthesis model
Published
2022-04-06
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

Contact Domains

Product Codes

CodeName
EGDWax, Dental, Intraoral

Product Code Classifications

CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06934906696972PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06934906696972069349066969726934906696972

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+863358357346yangmeng@aidite.com

Regulatory Flags

DUNS number
529607549
Device count
1
DM exempt
false
Premarket exempt
true
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
00840479203324RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-03-12
00840479203331RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-03-12
00840479200552RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23
00840479200569RELIAWAXRELIANCE ORTHODONTIC PRODUCTS INCEGD2026-02-23
06978785665070InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-12-08
10190707193215Orthosil™Ortho Organizers, Inc.EGD2025-10-23
10190707149045Comfort Cover™Ortho Organizers, Inc.EGD2025-10-01
10190707143005Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143012Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143029Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143036Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143043Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143050Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143067Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143074Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143081Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
10190707143098Ortho Performance®Ortho Organizers, Inc.EGD2025-09-30
E235S3DCR0DentaprintSHOFU DENTAL CORPORATIONEGD2025-08-26
07701126901150Portux 3D Printing Resin CastPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEGD2025-08-11
07701126901228Portux 3D Printing Resin CastPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEGD2025-08-11
00840456207604JMUJMU DENTAL, INCEGD2025-07-15
00840456207611JMUJMU DENTAL, INCEGD2025-07-15
00840456207628JMUJMU DENTAL, INCEGD2025-07-15
00840456207635JMUJMU DENTAL, INCEGD2025-07-15
00840456207642JMUJMU DENTAL, INCEGD2025-07-15
16978785665046InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-07-09
06978785665049InhwRiorShenzhen Yuechuan trade Co., Ltd.EGD2025-07-09
07506338322454ROGSON WAX, MDC Dental MDC DENTALEGD2025-05-16
00190886135498NAG & H Wire Company, Inc.EGD2025-03-31
00190886135559NAG & H Wire Company, Inc.EGD2025-03-31