FDA.reportPublic FDA data

prosthetics - Long Term abutments

Primary DI
07290114712903
Brand
prosthetics - Long Term abutments
Company
CORTEX - DENTAL IMPLANTS INDUSTRIES LTD
Model
MPR-6207
Catalog number
MPR-6207
Device description
Ball Attachment 7 mm MPR
Published
2026-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form
NHAAbutment, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163385000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163385000Cortex Dental Implant SystemCortex Dental Implants Industries , Ltd.2017-08-29DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290114712903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290114712903072901147129037290114712903

GMDN Terms#

Term, Definition table
TermDefinition
Bar dental precision attachmentA small shaft or splint typically made of austenitic alloys or alloys containing 75 percent or greater gold (Au) and metals of the platinum group, intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture. The device typically includes fixers (e.g., clasps, sleeves, or screws).

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
false
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
07290114712149prosthetics - AnalogMPN-8040MPN-80402026-10-06
07290114712767prosthetics - Long Term abutmentsMPR-5318MPR-53182026-10-06
07290114712774prosthetics - Long Term abutmentsMPR-5330MPR-53302026-10-06
07290114712781prosthetics - Long Term abutmentsMPR-5400MPR-54002026-10-06
07290114712798prosthetics - Long Term abutmentsMPR-5418MPR-54182026-10-06
07290114712804prosthetics - Long Term abutmentsMPR-5430MPR-54302026-10-06
07290114712811prosthetics - Long Term abutmentsMPR-5500MPR-55002026-10-06
07290114712828prosthetics - Long Term abutmentsMPR-5518MPR-55182026-10-06
07290114712835prosthetics - Long Term abutmentsMPR-5530MPR-55302026-10-06
07290114712842prosthetics - Long Term abutmentsMPR-6201MPR-62012026-10-06
07290114712859prosthetics - Long Term abutmentsMPR-6202MPR-62022026-10-06
07290114712866prosthetics - Long Term abutmentsMPR-6203MPR-62032026-10-06
07290114712873prosthetics - Long Term abutmentsMPR-6204MPR-62042026-10-06
07290114712880prosthetics - Long Term abutmentsMPR-6205MPR-62052026-10-06
07290114712897prosthetics - Long Term abutmentsMPR-6206MPR-62062026-10-06
07290114712910prosthetics - healing CapMPR-7102MPR-71022026-10-06
07290114712927prosthetics - healing CapMPR-7103MPR-71032026-10-06
07290114712934prosthetics - healing CapMPR-7104MPR-71042026-10-06
07290114712941prosthetics - healing CapMPR-7105MPR-71052026-10-06
07290114712958prosthetics - healing CapMPR-7106MPR-71062026-10-06

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