FDA.reportPublic FDA data

NA

Primary DI
06935835600009
Brand
NA
Company
Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
Model
HK-Y-0.4
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
16935835600006PackageGS150In Commercial Distribution
06935835600009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693583560000616935835600006
06935835600009069358356000096935835600009

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
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
06935835600405NAHK-Y-0.72023-10-09
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
00810222900060SportsGuard - Crimson RedSprintray, Inc.KMY2026-06-23
00810222900077SportsGuard - Cobalt BlueSprintray, Inc.KMY2026-06-23
00810222900084SportsGuard - ClearSprintray, Inc.KMY2026-06-23
04260670160510dentona flexisplintdentona AGMQC2026-06-23
04260670160527dentona flexisplintdentona AGMQC2026-06-23
04260670160534dentona flexisplintdentona AGMQC2026-06-23
04260670160541dentona flexisplintdentona AGMQC2026-06-23
04260670160558dentona flexisplintdentona AGMQC2026-06-23
04260670160572dentona flexisplintdentona AGMQC2026-06-23
04260670160589dentona flexisplintdentona AGMQC2026-06-23
04260670160596dentona vivatempdentona AGMQC2026-06-23
04260670160602dentona vivatempdentona AGMQC2026-06-23
04260670160619dentona vivatempdentona AGMQC2026-06-23
04260670160626dentona vivatempdentona AGMQC2026-06-23
04260670160633dentona vivatempdentona AGMQC2026-06-23
04260670160640dentona vivatempdentona AGMQC2026-06-23
04260670160657dentona vivatempdentona AGMQC2026-06-23
04260670160688optimill memosplintdentona AGMQC2026-06-23
04260670160695optimill memosplintdentona AGMQC2026-06-23
04260670160701optimill memosplintdentona AGMQC2026-06-23
04260670160718optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160725optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160732optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160749optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160756optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160664optimill memosplintdentona AGMQC2026-06-22
04260670160671optimill memosplintdentona AGMQC2026-06-22
EPRCD1001501printodent GR-19.1 OApro3dure medical GmbHMQC2023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIpro3dure medical GmbHMQC2023-08-29
EPRCD1001609PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06