FDA.reportPublic FDA data

OP

Primary DI
D742OPCT47110
Brand
OP
Company
INTRA-LOCK INTERNATIONAL, INC.
Model
OPCT4711
Catalog number
OPCT4711
Device description
One Piece™ CT Implant Ø4.75mm X 11.5mm
Published
2017-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K130140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130140000INTRA-LOCK OP DENTAL IMPLANTIntra-Lock International2013-08-01DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D742OPCT47110PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
8773300338info@intra-lock.com

Regulatory Flags#

DUNS number
131500998
Device count
1
Lot or batch
true
Expiration date on label
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
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08809984970291S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970307S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970314S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970345S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970352S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970369S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970376S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970390S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970406S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970062S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970079S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970086S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970123S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970154S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970161S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970178S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970185S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970192S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970208S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970222S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970239S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970246S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970253S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970260S-PlantIDIS CO.,LTDDZE2026-10-20