Aidite

Primary DI
06977132549971
Brand
Aidite
Company
Aidite (Qinhuangdao) Technology Co., Ltd.
Model
APMR02
Published
2024-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EHYTray, Impression, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHYTray, Impression, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977132549971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977132549971069771325499716977132549971

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental anatomy modelA dental device made of gypsum (e.g., plaster, dental stone) intended to be used as a replica (model) of a specific patient’s teeth and gums, to assist with a dental treatment-related procedure (e.g., production of a dental restoration, design of a teeth whitening tray). It is created via casting (i.e., taking the impression of the patient’s teeth/gums, pouring plaster into the impression, and then removing the impression). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529607549
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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

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Primary DI, Brand, Company table
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00190707110796DuraLock®Ortho Organizers, Inc.EHY2025-09-25
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07630392912013PRESIDENTDent4You AGEHY2024-11-22