FDA.reportPublic FDA data

NA

Primary DI
06935835600405
Brand
NA
Company
Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
Model
HK-Y-0.7
Published
2023-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KMYPositioner, Tooth, Preformed
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230237000Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.2023-09-14MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16935835600402PackageGS135In Commercial Distribution
06935835600405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693583560040216935835600402
06935835600405069358356004056935835600405

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Regulatory Flags#

DUNS number
410789418
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06935835600009NAHK-Y-0.42023-10-09
06935835600214NAHK-Y-0.452023-10-09
06935835600221NAHK-Y-0.632023-10-09
06935835600283NAHK-Y-0.72023-10-09
06935835600306NAHK-Y-ST-0.762023-10-09
06935835600337NAHK-Y-CF-0.762023-10-09
06935835600344NAHK-Y-0.92023-10-09
06935835600351NAHK-Y-1.02023-10-09
06935835600368NAHK-Y-2.02023-10-09
06935835600375NAHK-Y-0.42023-10-09
06935835600382NAHK-Y-0.452023-10-09
06935835600399NAHK-Y-0.632023-10-09
06935835600412NAHK-Y-ST-0.762023-10-09
06935835600429NAHK-Y-CF-0.762023-10-09
06935835600436NAHK-Y-0.92023-10-09
06935835600443NAHK-Y-1.02023-10-09
06935835600610NAHK-Y-2.02023-10-09
16935835600006NAHK-Y-0.42023-10-09
16935835600211NAHK-Y-0.452023-10-09
16935835600228NAHK-Y-0.632023-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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EPRCD1001504printodent GR-19.1 OA I MSIpro3dure medical GmbHMQC2023-08-29
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EPRCD1001609PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001610PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001611PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001703PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRCD1001704PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRC66077916dima Print Splint clear pro3dure medical GmbHMQC2021-11-25
EPRC66077916dima Print Splint clear pro3dure medical GmbHKMY2021-11-25
EPRCD1000800PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1000801PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1001491PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001492PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001493PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001701PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
EPRCD1001702PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
ERKO5142052ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5142072ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5142102ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5212051ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5212401ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5215081ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5215401ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5219061Erkodur-A1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5222061Erkodur-A1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5222101Erkodur-A1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5222201Erkodur-A1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5226061Erkodur-0M1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5226101Erkodur-0M1Erkodent Erich Kopp GmbHKMY2021-09-21