FDA.reportPublic FDA data

Intra-Lock

Primary DI
D742FTTC0
Brand
Intra-Lock
Company
INTRA-LOCK INTERNATIONAL, INC.
Model
FTTC
Catalog number
FTTC
Device description
FLAT TOP™ Titanium Cylinder, w/ Retaining Screw
Published
2019-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K021322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021322000ENDOSSOUS IMPLANTSIntra-Lock International2002-07-24DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D742FTTC0PrimaryHIBCC0

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
131500998
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D742RP10ReOssRP1RP12017-02-08
D742RP20ReOssRP2RP22017-02-08
D742RP30ReOssRP3RP32017-02-08
D742RP40ReOssRP4RP42017-02-08
D742RP60ReOssRP6RP62017-02-08
D742RP70ReOssRP7RP72017-02-08
D742DE0Intra-LockDEDE2019-06-24
D742S47100BlossomS4710S47102020-03-17
D742S47110BlossomS4711S47112020-03-17
D742S47060BlossomS4706S47062019-06-12
D742S47080BlossomS4708S47082019-06-12
D742MDLOP25130MDLMDLOP2513MDLOP25132017-02-06
D742MDLOP25150MDLMDLOP2515MDLOP25152017-02-06
D742OP30100OPOP3010OP30102017-02-07
D742OP3011OPOP3011OP30112017-02-13
D742OP3013OPOP3013OP30132017-02-13
D742OP30150OPOP3015OP30152017-02-07
D742S34080BlossomS3408S34082017-02-07
D742S34100BlossomS3410S34102017-02-07
D742S34110BlossomS3411S34112017-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809918260054LW Narrow Solid AbutmentOssvis Co., Ltd.NHA2026-10-22
08809918260085LW Narrow Solid AbutmentOssvis Co., Ltd.NHA2026-10-22
08809984988135S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988210S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988296S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988333S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988371S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988418S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988456S-PlantIDIS CO.,LTDNHA2026-10-22
08809984987886S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987909S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987923S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987947S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987961S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987985S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988005S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988029S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988043S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988067S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988098S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988173S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988258S-PlantIDIS CO.,LTDNHA2026-10-21
088000968494068plant Implant System8dent Inc.NHA2026-10-20
088000968498338plant Implant System8dent Inc.NHA2026-10-20
088000968514618plant Implant System8dent Inc.NHA2026-10-20
088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20