FDA.reportPublic FDA data

Korticale TPR IH

Primary DI
D169BPIH3510
Brand
Korticale TPR IH
Company
QUICKDENT DEVICES PRIVATE LIMITED
Model
3.5 x 10mm
Catalog number
BITP3510IH
Published
2025-07-01
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
D169BPIH3510PrimaryHIBCC0

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
07630031742124Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742131Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742148Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742155Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742162Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742179Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742186Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742193Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742209Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742216Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742223Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742230Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742247Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742254Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742407Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742414Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742421Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742438Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742445Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742452Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742469Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742476Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742483Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742490Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742506Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742513Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742520Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742537Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742612Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06
07630031742629Straumann TLX Implant SystemInstitut Straumann AGDZE2020-11-06