FDA.reportPublic FDA data

Locator Insert

Primary DI
07290111513596
Brand
Locator Insert
Company
D.A.N.D METAL INDUSTRIES NORTH LTD
Model
White
Catalog number
CN086
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
07290111513596PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290111513596072901115135967290111513596

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.

Regulatory Flags#

DUNS number
514749923
Device count
1
Lot or batch
true
Expiration date on label
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
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNHA2026-07-13
07290114710411Healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712156Abutments-AnalogCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
07290114712613Titanium-basesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-07-12
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092184394PreatPreat CorporationNHA2025-07-24
D762MUA030500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA031000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA032000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA033000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA034000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345HCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345TBM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA0345VCM0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA035000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA040500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA041000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA042000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA043000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA044000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA045000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA050500M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA051000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA052000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA053000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA054000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762MUA055000M0Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS0300010Implant-OneImplant Logistics, Inc.NHA2024-12-06
D762THS1635230Implant-OneImplant Logistics, Inc.NHA2024-12-06