FDA.reportPublic FDA data

IH screw for plastic and titanium Multi Unit sleeves

Primary DI
07290111511301
Brand
IH screw for plastic and titanium Multi Unit sleeves
Company
D.A.N.D METAL INDUSTRIES NORTH LTD
Model
SSFMUk
Catalog number
SSFMUk
Published
2025-10-15
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
K250176000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250176000DAND Dental Implant SystemD.A.N.D. Metal Industries North, Ltd.2025-04-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290111511301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290111511301072901115113017290111511301

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
514749923
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290111512186IH Hand Wrench Adaptor 6.35mm6.35mmHW2025-11-30
07290111512247IH Hand Driver 2.42mm2.42mmHD2025-11-30
07290111510885IH POP UP TRANSFER ABUTMENT1mmTRAS12025-10-24
07290111510892IH POP UP TRANSFER ABUTMENT2mmTRAS22025-10-24
07290111510908IH POP UP TRANSFER ABUTMENT3mmTRAS32025-10-24
07290111510915IH POP UP TRANSFER ABUTMENT4mmTRAS42025-10-24
07290111511288IH Multi Unit Transfer ScrewSSFTMUkSSFTMUk2025-10-24
07290111511615IH Digital AnalogDAN37HDAN37H2025-10-24
07290111511622Conical NP Digital AnalogDAN37CDAN37C2025-10-24
07290111511639IH Multi Unit Digital AnalogDANMUADANMUA2025-10-24
07290111511783SCAN BODY IHSCAN BODY IHSCANPH2025-10-24
07290111511790SCAN BODY CONICAL NPSCAN BODY CONICAL NPSCANPC2025-10-24
07290111511813SCAN BODY Straight Multi Unit IHSCAN BODY Straight MU IHSCOD022025-10-24
07290111511882IH Transfer Screw14mmSSFT142025-10-24
07290111511899IH Transfer Screw16mmSSFT162025-10-24
07290111511905IH Transfer Screw22mmSSFT222025-10-24
07290111511936IH Implant Analog3.75mmSIA3752025-10-24
07290111511943IH Implant Analog5.00mmSIA5002025-10-24
07290111511950IH and Conical NP RP Straight Multi Unit AnalogSAFMUkSAFMUk2025-10-24
07290111511967IH and Conical NP RP Locator AnalogSAFLSAFL2025-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256624ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256631ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256648ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256655ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260690ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260706ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260737ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260744ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260973ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22