FDA.reportPublic FDA data

GDT MOR Spiral Implant

Primary DI
D150M5010
Brand
GDT MOR Spiral Implant
Company
GLOBAL DENTAL TRANSFER LTD
Model
5.0 x 10mm
Catalog number
M5010
Published
2025-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200188000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200188000DSI Dental Implant SystemDsi Dental Solutions, Ltd.2020-04-01DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D150M5010PrimaryHIBCC0

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
532376847
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290123172224IH Popup Transfer Abutment 1mmSOC12026-01-21
07290123172231IH Popup Transfer Abutment 2mmSOC22026-01-21
07290123172248IH Popup Transfer Abutment 3mmSOC32026-01-21
07290123172255IH Popup Transfer Abutment 4mmSOC42026-01-21
07290123172262IH Multi Unit Transfer Screw SSFTMU-kSSFTMU-k2026-01-21
07290123172279IH Transfer Screw 14mmSSFT 142026-01-21
07290123172286IH Transfer Screw 16mmSSFT 162026-01-21
07290123172293IH Transfer Screw 22mmSSFT 222026-01-21
07290123172309IH Implant Analog3.75ANG2026-01-21
07290123172316IH Implant Analog5.00ANGW2026-01-21
07290123172323IH NP RP Straight and Angled Multi Unit AnalogMUANGMUANG2026-01-21
07290123172330IH NP RP Locator AnalogAFLAFL2026-01-21
07290123172347IH Transfer13mmSTRC2026-01-21
07290123172354IH Transfer09mmSTRO2026-01-21
07290123172361IH Transfer Clips13mmCTR132026-01-21
07290123172378IH Transfer Clips09mmCTR92026-01-21
07290123172385IH Multi Unit TransferMUTOTMUTOT2026-01-21
07290123172392IH Hand Driver Key 1.25mmL7mmHHD12072026-01-21
07290123172408IH Hand Driver Key 1.25mmL10mmHHD12102026-01-21
07290123172415IH Hand Driver Key 1.25mmL15mmHHD12152026-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516878418SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878425SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878432SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878449SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878456SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878715SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878722SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878739SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878746SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878753SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879613SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879620SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879637SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879644SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879651SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879668SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879675SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879682SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879699SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879705SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879712SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879729SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879736SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879743SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879750SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879767SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879774SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879781SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879798SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879804SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04