FDA.reportPublic FDA data

Korticale SP

Primary DI
D169BISP4214
Brand
Korticale SP
Company
QUICKDENT DEVICES PRIVATE LIMITED
Model
4.2 x 14mm
Catalog number
BISP4214
Published
2025-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243094000Quickdent Dental Implant SystemQuickdent Devices Private , Ltd.2024-12-19DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D169BISP4214PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant into alveolar and/ or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
860405444
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
D16900000DP0Disc for Ball AttachmentDPDP2025-10-01
D169000SLNP1Quicksnap CC NP1mmSL-1-NP2025-10-01
D169000SLNP2Quicksnap CC NP2mmSL-2-NP2025-10-01
D169000SLNP3Quicksnap CC NP3mmSL-3-NP2025-10-01
D169000SLNP4Quicksnap CC NP4mmSL-4-NP2025-10-01
D169000SLRP1Quicksnap CC RP1mmSL-1-RP2025-10-01
D169000SLRP2Quicksnap CC RP2mmSL-2-RP2025-10-01
D169000SLRP3Quicksnap CC RP3mmSL-3-RP2025-10-01
D169000SLRP4Quicksnap CC RP4mmSL-4-RP2025-10-01
D16900SCANP0Conical Abutment Screw NPSCASCA-NP2025-10-01
D16900SCARP0Conical Abutment Screw RPSCASCA-RP2025-10-01
D1690CSCNP06Conical Cover Screw NPCSCCSC-NP-062025-10-01
D1690CSCRP06Conical Cover Screw RPCSCCSC-RP-062025-10-01
D1690HCC2NP0Conical Healing Cap NP2mmHCC-2-NP2025-10-01
D1690HCC2RP0Conical Healing Cap RP2mmHCC-2-RP2025-10-01
D1690HCC3NP0Conical Healing Cap NP3mmHCC-3-NP2025-10-01
D1690HCC3RP0Conical Healing Cap RP3mmHCC-3-RP2025-10-01
D1690HCC4NP0Conical Healing Cap NP4mmHCC-4-NP2025-10-01
D1690HCC4RP0Conical Healing Cap RP4mmHCC-4-RP2025-10-01
D1690HCC5NP0Conical Healing Cap NP5mmHCC-5-NP2025-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806395200535Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200542Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200559Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200566Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200573Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200580Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200597Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200603Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200610Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200627Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200634Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200641Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200658Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200665Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200672Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200689Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200696Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200702Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200719Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200726Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200733Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200740Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200757Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200764Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200771Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200788Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200795Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200801Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200818Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28
08806395200825Ufit Dental ImplantT Strong Co., Ltd.DZE2026-05-28