FDA.reportPublic FDA data

Intra-Lock

Primary DI
D742IFANT0
Brand
Intra-Lock
Company
INTRA-LOCK INTERNATIONAL, INC.
Model
IFANT
Catalog number
IFANT
Device description
FlatOne® Abutment Transfer, Narrow , w/ Retaining Screw
Published
2019-09-18
Public version status
Update
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
NDPAccessories, Implant, Dental, Endosseous
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103194000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103194000INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOMIntra-Lock International, Inc.2011-04-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D742IFANT0PrimaryHIBCC0

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
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
00810112922530(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922547(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922554(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922561(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922578(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922585(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922592(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922608(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922615(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922622(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922639(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922646(INOSS System) Stock AbutmentInosys, Inc.NHA2026-08-27
00810112922653(INOSS System) Abutment ScrewInosys, Inc.NHA2026-08-27
08059224151496OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151502OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224151588OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224217932OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217949OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217956OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217963OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217970OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217987OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224217994OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218021OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218045OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218052OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218069OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218076OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218083OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27
08059224218090OT EQUATOR TITANIUM ABUTMENTRHEIN 83 SRLNHA2026-08-27