FDA.reportPublic FDA data

Abutment IH

Primary DI
07290111510656
Brand
Abutment IH
Company
D.A.N.D METAL INDUSTRIES NORTH LTD
Model
7mm
Catalog number
STA7
Published
2025-10-14
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
07290111510656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290111510656072901115106567290111510656

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
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