FDA.reportPublic FDA data

Intra-Lock

Primary DI
D742LOC85470
Brand
Intra-Lock
Company
INTRA-LOCK INTERNATIONAL, INC.
Model
LOC8547
Catalog number
LOC8547
Device description
LOCATOR® EXTENDED RANGE REPLACEMENT MALE
Published
2019-07-10
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
NYEFixture Mount Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYEFixture Mount KitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D742LOC85470PrimaryHIBCC0

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
D742S34130BlossomS3413S34132017-02-07
D742S34150BlossomS3415S34152017-02-07
D742S37080BlossomS3708S37082017-02-07
D742S37100BlossomS3710S37102017-02-07
D742S37110BlossomS3711S37112017-02-07
D742S37130BlossomS3713S37132017-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06947600330943BLT Guided KitBIO CONCEPT Co., Ltd.NYE2026-05-27
08800342290136OneArch Scan Body KITOsstem Implant Co., Ltd.NYE2026-04-02
08800342289710OneArch Scan Body KITOsstem Implant Co., Ltd.NYE2026-03-05
008500733335703DDX Tapered Drill Kit 3D DIAGNOSTIX, INC.NYE2025-09-10
008500733335633DDX Straight Drill Kit3D DIAGNOSTIX, INC.NYE2025-09-10
08800271260286122 TAPER FULL KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260293122 TAPER KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260309485 KITOsstem Implant Co., Ltd.NYE2025-09-05
08800271260316TAPER KITOsstem Implant Co., Ltd.NYE2025-09-05
06947600302094TL MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304388BL MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304395BLT MINI KITBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304654BC Removal Kit,BCJJ-SBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600304661BC Removal Kit,BCJJ-LBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600316350BV Removal Kit,BVJJ-LBIO CONCEPT Co., Ltd.NYE2025-03-25
06947600316589BV MINI KitBIO CONCEPT Co., Ltd.NYE2025-03-25
08800271240516Bone Compaction KITOsstem Implant Co., Ltd.NYE2025-02-03
08800271241544Bone Compaction KITOsstem Implant Co., Ltd.NYE2025-02-03
08800271234409OneArch KITOsstem Implant Co., Ltd.NYE2025-01-03
08800271229733485 KITOsstem Implant Co., Ltd.NYE2024-12-10
08800271233976OneArch KITOsstem Implant Co., Ltd.NYE2024-12-09
06947600319948BV Standard KlTBIO CONCEPT Co., Ltd.NYE2024-11-27
08800271219987Bone Compaction KITOsstem Implant Co., Ltd.NYE2024-09-26
08800271219994Bone Compaction KITOsstem Implant Co., Ltd.NYE2024-09-26
06947600316596BV Guided Kit,BVBIO CONCEPT Co., Ltd.NYE2024-09-18
08800271225438SIMPLE KITOsstem Implant Co., Ltd.NYE2024-09-10
08800271218409Taper Ultra KITOsstem Implant Co., Ltd.NYE2024-08-20
08800271218416Taper Ultra KITOsstem Implant Co., Ltd.NYE2024-08-20
08809917070012122 Taper Full KITOsstem Implant Co., Ltd.NYE2024-08-20
08809917070029122 Taper KITOsstem Implant Co., Ltd.NYE2024-08-20