FDA.reportPublic FDA data

Aidite Dental Bur

Primary DI
06934906699461
Brand
Aidite Dental Bur
Company
Aidite (Qinhuangdao) Technology Co., Ltd.
Model
Aidite
Device description
Used for grinding and polishing denture
Published
2022-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJLBur, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJLBur, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06934906699461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06934906699461069349066994616934906699461

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+863358357346yangmeng@aidite.com

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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07630049951051Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951075Carbide bur Diacarb RADiaswiss SAEJL2023-10-02
07630049951532Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049951556FG Diacarb finishing bur HCDiaswiss SAEJL2023-10-02
07630049951921C141 Allport bone cutterDiaswiss SAEJL2023-10-02
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07630049952003Carbide finishing bur Diacarb RADiaswiss SAEJL2023-10-02
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07630049952065Carbide bur Diacarb FG HCDiaswiss SAEJL2023-10-02
07630049952089FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952164FG Diacarb finishing burDiaswiss SAEJL2023-10-02
07630049952188FG Diacarb finishing burDiaswiss SAEJL2023-10-02
ESUNC283K3140165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-25
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ESUNCC11040185Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNCC11040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
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ESUNTC1S2040145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040165Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040215Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNTC1S2040235Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-23
ESUNC463140145Sunshine DiamondsDr. Hopf GmbH & Co. KGEJL2023-07-07