FDA.reportPublic FDA data

IH Straight Abutment

Primary DI
D169000STA11
Brand
IH Straight Abutment
Company
QUICKDENT DEVICES PRIVATE LIMITED
Model
11mm
Catalog number
STA11
Published
2025-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

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
D169000STA11PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
860405444
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
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
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
EMKA03117ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA10503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA20503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA40503ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-12
EMKA02821ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03110ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03114ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA03115ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA10502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA20502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA40502ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8509ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851517ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA851530ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKA8515TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAB80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS81PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS82PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKABS83PSET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC80TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC81TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82ET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11
EMKAC82TET9MEDENTiKAMEDENTiKA GmbHNHA2019-06-11