FDA.reportPublic FDA data

Classix Hex (Premium)

Primary DI
07290112781536
Brand
Classix Hex (Premium)
Company
CORTEX - DENTAL IMPLANTS INDUSTRIES LTD
Model
PCSC-1150
Catalog number
PCSC-1150
Device description
Classix Dental Implant 5.0mm 11.5mm L Premium
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
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
K090709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090709000CORTEX DENTAL IMPLANT SYSTEMCortex Dental Implants Industries , Ltd.2009-07-07DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290112781533PackageGS110In Commercial Distribution
07290112781536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011278153317290112781533
07290112781536072901127815367290112781536

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature00
Special Storage Condition, Specify00KEEP AWAY FROM SUNLIGHT
Special Storage Condition, Specify00keep Dry

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290114710756prosthetics - TransferCO-8070CO-80702026-10-14
07290114710787prosthetics - Long Term abutmentsCO-8075CO-80752026-10-14
07290114710800prosthetics - Long Term abutmentsCO-8080CCO-8080C2026-10-14
07290114710831prosthetics - Long Term abutmentsCO-8100CO-81002026-10-14
07290114710848prosthetics - Long Term abutmentsCO-8100CCO-8100C2026-10-14
07290114711654prosthetics - Long Term abutmentsCO-TBCRCCO-TBCRC2026-10-14
07290114711661prosthetics - Long Term abutmentsCO-TBCRCRCO-TBCRCR2026-10-14
07290114712026prosthetics - Long Term abutmentsMPN-5418MPN-54182026-10-14
07290114712170prosthetics - Long Term abutmentsMPN-8080MPN-80802026-10-14
07290114712651prosthetics - Long Term abutmentsMPN-TBR2MPN-TBR22026-10-14
07290114712668prosthetics - Long Term abutmentsMPN-TBR3MPN-TBR32026-10-14
07290114713054prosthetics -TransferMPR-8080MPR-80802026-10-14
07290114713429prosthetics - Long Term abutmentsMPR-TBCRCRMPR-TBCRCR2026-10-14
07290114713948prosthetics - Long Term abutmentsMPW-9215MPW-92152026-10-14
07290114714570prosthetics -Cover screwMPW-S006MPW-S0062026-10-14
07290116660295Surgical DrillsCD-GS1037CD-GS10372026-10-14
07290116662046Surgical DrillsCD-GS1041CD-GS10412026-10-14
07290114711548prosthetics - Long Term abutmentsCO-S030CO-S0302026-10-13
07290114711630prosthetics - Long Term abutmentsCO-SBZZCO-SBZZ2026-10-13
07290114712491prosthetics - Long Term abutmentsMPN-S030MPN-S0302026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968582008plant Implant System8dent Inc.NHA2026-11-04
088000968584398plant Implant System8dent Inc.NHA2026-11-04
088000968586998plant Implant System8dent Inc.NHA2026-11-04
088000968602108plant Implant System8dent Inc.NHA2026-11-04
088000968602278plant Implant System8dent Inc.NHA2026-11-04
088000968612318plant Implant System8dent Inc.NHA2026-11-04
088000968612488plant Implant System8dent Inc.NHA2026-11-04
088000968622908plant Implant System8dent Inc.NHA2026-11-04
088000968686058plant Implant System8dent Inc.NHA2026-11-04
088000968788578plant Implant System8dent Inc.NHA2026-11-04
00840481137181LOCATOR Angled AbutmentZest Anchors, LLCNHA2026-11-03
08800077000031ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000055ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000079ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000093ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000116ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000130ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000154ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000178ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000192ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000215ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000239ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000253ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000277ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000291ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000321ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000345ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000369ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000383ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30
08800077000406ZEROS Dental Implant SystemZEROS Co., Ltd.DZE2026-10-30