FDA.reportPublic FDA data

PROSTHETIC SCREWS

Primary DI
07290113352599
Brand
PROSTHETIC SCREWS
Company
DENTIN IMPLANTS TECHNOLOGIES LTD
Model
DSC-0040
Device description
Screw for Castable Abutments 3mm
Published
2018-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K120530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120530000DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION SDentin Implants Technologies , Ltd.2012-07-05DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290113352599PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290113352599072901133525997290113352599

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA non-sterile device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600215680
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290113355941TREPHINE DRILLDDR-TR032018-09-10
07290113355958TREPHINE DRILLDDR-TR042018-09-10
07290113355965TREPHINE DRILLDDR-TR052018-09-10
07290113356252IMPLANTOLOGY TOOLSDCT-08002018-09-10
07290113356269IMPLANTOLOGY TOOLSDCT-08102018-09-10
07290113356917PROSTHETIC SCREWSSSU-16242019-09-11
072901133538793D SCANNINGGAHM-002018-09-10
072901133538863D SCANNINGGAHM-092018-09-10
072901133538933D SCANNINGGAHM-182018-09-10
072901133539093D SCANNINGGAHM-302018-09-10
072901133545003D SCANNINGSMS-00402018-09-10
072901133545173D SCANNINGSMS-60402018-09-10
072901133545863D SCANNINGSWS-00402018-09-10
072901133545933D SCANNINGSWS-60402018-09-10
07290113356832PROSTHETIC SCREWSDTR-SC112019-05-15
07290113356825PROSTHETIC SCREWSSMU-40232019-04-17
07290113352537PROSTHETIC SCREWSDSC-00202018-09-10
07290113352544PROSTHETIC SCREWSDSC-00302018-09-10
07290113352605PROSTHETIC SCREWSDSC-00502018-09-10
07290113352674PROSTHETIC SCREWSDSC-00102018-09-10

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