FDA.reportPublic FDA data

CC Anatomic Restoration Kit H1mm L6mm

Primary DI
07290118142614
Brand
CC Anatomic Restoration Kit H1mm L6mm
Company
NOGA MEDICAL PRODUCTS LTD
Model
A
Catalog number
PF2-ARK16
Device description
CC Anatomic Restoration Kit H1mm L6mm
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290118142614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290118142614072901181426147290118142614

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
600763386
Device count
1
Kit
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290118144175CC Temporary Abutment H1mm PEEKAPT2-00012025-11-22
07290118144182CC Temporary Abutment H2mm PEEKAPT2-00022025-11-22
07290118144199CC Temporary Abutment H3mm PEEKAPT2-00032025-11-22
07290118144205CC 15° Temporary Abutment H1mm PEEKAPT2-00042025-11-22
07290118144212CC 15° Temporary Abutment H2mm PEEKAPT2-00052025-11-22
07290118144229CC 15° Temporary Abutment H3mm PEEKAPT2-00062025-11-22
07290118144236CC 25° Temporary Abutment H1mm PEEKAPT2-00072025-11-22
07290118144243CC 25° Temporary Abutment H2mm PEEKAPT2-00082025-11-22
07290118144250CC 25° Temporary Abutment H3mm PEEKAPT2-00092025-11-22
07290118145660CC Key 2.42 ShortATK2-00012025-11-22
07290118145677CC Key 2.42 LongATK2-00022025-11-22
07290118145684CC Implant IndicatorATK2-00052025-11-22
07290118145691CC Hand Tool 2.42 ShortATK2-00062025-11-22
07290118145707CC Hand Tool 2.42 LongATK2-00072025-11-22
07290118145714"CC 1/4"" Abutment Fixture Long"ATK2-00102025-11-22
07290118145721CC Handle Key 2.42mmATK2-00112025-11-22
07290118145738CC Screw Removal Burr GuideATK2-00122025-11-22
07290118145745CC Mock Abutment AnalogATK2-00142025-11-22
07290118145752CC Mock Abutment Analog 15°ATK2-00152025-11-22
07290118145769CC Mock Abutment Analog 25°ATK2-00162025-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256624ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256631ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256648ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256655ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260690ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260706ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260737ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260744ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260973ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22