FDA.reportPublic FDA data

Compact RobiCone Surgical Kit

Primary DI
07290118141242
Brand
Compact RobiCone Surgical Kit
Company
NOGA MEDICAL PRODUCTS LTD
Model
B
Catalog number
KT2-0001
Device description
Compact RobiCone Surgical Kit
Published
2024-08-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290118141242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290118141242072901181412427290118141242

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
Premarket exempt
true
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
07898488905190INSTRUMENT FOR ICERAM SLB BRACKETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211187CERAMIC NANO TUBE TWEEZERORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
07908611211255CURVERD SCISSORS FOR ALIGNERSORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZN2026-05-27
G149TBSB7500TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7510TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7520TBS BASICSACME ENTERPRISE.DZN2026-05-21
G149TBSB7530TBS BASICSACME ENTERPRISE.DZN2026-05-21
08404535018929Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535018950Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019049Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019131Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
08404535019162Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
07908854000647Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000654Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000661Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000678Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000838Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000883Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854000890Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001040Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001071Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001163Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001170Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001354Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001460Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001477Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001484Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001491Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22
07908854001507Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2025-05-22