FDA.reportPublic FDA data

Locator Conical NP

Primary DI
07290111513152
Brand
Locator Conical NP
Company
D.A.N.D METAL INDUSTRIES NORTH LTD
Model
2mm
Catalog number
SL2NP
Published
2025-10-17
Public version status
New
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
07290111513152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290111513152072901115131527290111513152

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