FDA.reportPublic FDA data

Conical NP Straight and Angled Multi-Unit Screw

Primary DI
07290117802946
Brand
Conical NP Straight and Angled Multi-Unit Screw
Company
R.D.J. TOV IMPLANT LTD
Model
SSFMU
Catalog number
SSFMU
Published
2025-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
07290117802946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290117802946072901178029467290117802946

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
600199501
Device count
1
Lot or batch
true
Sterilization required before use
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
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
07290117802687Conical RP Ball Attachment5mmCAB5 RP2025-02-19

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