FDA.reportPublic FDA data

Double Loc / Conical Retentor Housing

Primary DI
07290117801437
Brand
Double Loc / Conical Retentor Housing
Company
R.D.J. TOV IMPLANT LTD
Model
SMCFL
Catalog number
SMCFL
Published
2025-02-17
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
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240837000TOV Dental Implant SystemRdj Tov Implant, Ltd.2024-08-15DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290117801437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290117801437072901178014377290117801437

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

Regulatory Flags#

DUNS number
600199501
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117802915IH Straight Multi-Unit ScrewSCRWMUSCRWMU2025-02-26
07290117802922IH Angled Multi-Unit ScrewSCRWMUASCRWMUA2025-02-26
07290117802939Conical RP Straight and Angled Multi-Unit ScrewSCRHTRODSCRHTROD2025-02-26
07290117802946Conical NP Straight and Angled Multi-Unit ScrewSSFMUSSFMU2025-02-26
07290117802526IH Ball Attachment2mmAB22025-02-19
07290117802533IH Ball Attachment3mmAB32025-02-19
07290117802540IH Ball Attachment4mmAB42025-02-19
07290117802557IH Ball Attachment5mmAB52025-02-19
07290117802564IH Ball Attachment6mmAB62025-02-19
07290117802571IH Ball Attachment7mmAB72025-02-19
07290117802588Conical NP Ball Attachment1mmCAB12025-02-19
07290117802595Conical NP Ball Attachment2mmCAB22025-02-19
07290117802601Conical NP Ball Attachment3mmCAB32025-02-19
07290117802618Conical NP Ball Attachment4mmCAB42025-02-19
07290117802625Conical NP Ball Attachment5mmCAB52025-02-19
07290117802632Conical NP Ball Attachment6mmCAB62025-02-19
07290117802649Conical RP Ball Attachment1mmCAB1 RP2025-02-19
07290117802656Conical RP Ball Attachment2mmCAB2 RP2025-02-19
07290117802663Conical RP Ball Attachment3mmCAB3 RP2025-02-19
07290117802670Conical RP Ball Attachment4mmCAB4 RP2025-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290112853103NAUNIQA DENTAL LTDNHA2026-07-19
07290112854148NAUNIQA DENTAL LTDNHA2026-07-19
07290112854407NAUNIQA DENTAL LTDNHA2026-07-19
07290112854414NAUNIQA DENTAL LTDNHA2026-07-19
07290112855138NAUNIQA DENTAL LTDNHA2026-07-19
07290112855145NAUNIQA DENTAL LTDNHA2026-07-19
07290112855152NAUNIQA DENTAL LTDNHA2026-07-19
07290112855169NAUNIQA DENTAL LTDNHA2026-07-19
07290112855749NAUNIQA DENTAL LTDNHA2026-07-19
07290112855756NAUNIQA DENTAL LTDNHA2026-07-19
07290112855763NAUNIQA DENTAL LTDNHA2026-07-19
07290112855770NAUNIQA DENTAL LTDNHA2026-07-19
07290112856692NAUNIQA DENTAL LTDNHA2026-07-19
07290112857637NAUNIQA DENTAL LTDNHA2026-07-19
07290118030003NAUNIQA DENTAL LTDNHA2026-07-19
07290118030010NAUNIQA DENTAL LTDNHA2026-07-19
07290118177333NAUNIQA DENTAL LTDNHA2026-07-19
07290118177340NAUNIQA DENTAL LTDNHA2026-07-19
07290118177357NAUNIQA DENTAL LTDNHA2026-07-19
07290118177364NAUNIQA DENTAL LTDNHA2026-07-19
07290118177371NAUNIQA DENTAL LTDNHA2026-07-19
07290118177388NAUNIQA DENTAL LTDNHA2026-07-19
07290118177395NAUNIQA DENTAL LTDNHA2026-07-19
07290118177425NAUNIQA DENTAL LTDNHA2026-07-19
07290118177432NAUNIQA DENTAL LTDNHA2026-07-19
07290118177449NAUNIQA DENTAL LTDNHA2026-07-19
07290118177456NAUNIQA DENTAL LTDNHA2026-07-19
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092185391PreatPreat CorporationNHA2025-12-22