FDA.reportPublic FDA data

Surgical Tools

Primary DI
07290116661322
Brand
Surgical Tools
Company
CORTEX - DENTAL IMPLANTS INDUSTRIES LTD
Model
MCT-N215
Catalog number
MCT-N215
Device description
HandPiece Implant Driver L15 mm for Narrow
Published
2026-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290116661322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290116661322072901166613227290116661322

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00keep Dry

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
532376956
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290114710039Abutments Prosthetic AccessoriesCO-0622CO-06222026-10-11
07290114710046prosthetics - Long Term abutmentsCO-0630CO-06302026-10-11
07290114710114prosthetics - Long Term abutmentsCO-5130CO-51302026-10-11
07290114710138prosthetics - Long Term abutmentsCO-5218CO-52182026-10-11
07290114710145prosthetics - Long Term abutmentsCO-5230CO-52302026-10-11
07290114710312Abutments Prosthetic AccessoriesCO-6201CO-62012026-10-11
07290114710732Indirect Transfer 13mm open trayCO-8065CO-80652026-10-11
07290116660141Surgical DrillsCD-5003CD-50032026-10-11
07290114712675prosthetics - Long Term abutmentsMPR-0055MPR-00552026-10-07
07290114712682prosthetics - Long Term abutmentsMPR-0070MPR-00702026-10-07
07290114712699prosthetics - Long Term abutmentsMPR-5100MPR-51002026-10-07
07290114712705prosthetics - Long Term abutmentsMPR-5118MPR-51182026-10-07
07290114712712prosthetics - Long Term abutmentsMPR-5130MPR-51302026-10-07
07290114712729prosthetics - Long Term abutmentsMPR-5200MPR-52002026-10-07
07290114712736prosthetics - Long Term abutmentsMPR-5218MPR-52182026-10-07
07290114712743prosthetics - Long Term abutmentsMPR-5230MPR-52302026-10-07
07290114712750prosthetics - Long Term abutmentsMPR-5300MPR-53002026-10-07
07290114712149prosthetics - AnalogMPN-8040MPN-80402026-10-06
07290114712767prosthetics - Long Term abutmentsMPR-5318MPR-53182026-10-06
07290114712774prosthetics - Long Term abutmentsMPR-5330MPR-53302026-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053071N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053088N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053095N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053101N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053118N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053125N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053132N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053149N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053156N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053163N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053248N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053293N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053347N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053354N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053361N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544053415N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
07640149886726TRITRI Dental Implants Int. AGNDP2026-10-06
07640149886733TRITRI Dental Implants Int. AGNDP2026-10-06