FDA.reportPublic FDA data

GDT MOR Spiral Implant

Primary DI
D150M5011
Brand
GDT MOR Spiral Implant
Company
GLOBAL DENTAL TRANSFER LTD
Model
5.0 x 11.5mm
Catalog number
M5011
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
D150M5011PrimaryHIBCC0

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
07290114710329Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710428prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710442prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710459prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710480Concave Hex. Healing Cap 6.mmCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710510prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710527prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710862prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710879prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710886prosthetics - healing CapCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114710985prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711005prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711210Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711456prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711487Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711500Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711524Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114711678Attachments- Abutments ProstheticCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114712163prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114712255prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290114712262prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-01
07290112780041Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780058Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780065MAGIX Dental Implant Ø4.2 L10mm PrimeCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780072Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780089Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780096Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780102Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780119Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29
07290112780126Magix (Prime)CORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-09-29