FDA.reportPublic FDA data

Metallic Abutment

Primary DI
07899995207708
Brand
Metallic Abutment
Company
Sin Sistema de Implante Nacional S/A
Model
EUCLA 366-Q
Catalog number
EUCLA 366-Q
Device description
PLASTIC ABUTMENT CR-CO Ø 4.1 W/ PTQ2008
Published
2022-06-30
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170398000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170398000S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.2017-11-21DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899995207708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995207708078999952077087899995207708

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
904569092
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899995223999ORGANIZER BOX VERSALISCOSV 01ENCOSV 01EN2026-10-29
07899995226457SLEEVE FOR SURGICAL GUIDEØ5.1MM OPENAGA 51-10AGA 51-102026-10-29
07899995226464SLEEVE FOR SURGICAL GUIDE Ø5.1MM OPENAGA 51-5AGA 51-52026-10-29
07899995226471SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPENAGA 39-10AGA 39-102026-10-29
07899995226488SLEEVE FOR SURGICAL GUIDE Ø3.9MM OPENAGA 39-5AGA 39-52026-10-29
07899995226495SLEEVE FOR SURGICAL GUIDE Ø5.1MMAG 51-10AG 51-102026-10-29
07899995226501SLEEVE FOR SURGICAL GUIDE Ø5.1MMAG 51-5AG 51-52026-10-29
07899995226518SLEEVE FOR SURGICAL GUIDE Ø3.9MMAG 39-10AG 39-102026-10-29
07899995226525SLEEVE FOR SURGICAL GUIDE Ø3.9MMAG 39-5AG 39-52026-10-29
07899995226532SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALAFGP 20-10AFGP 20-102026-10-29
07899995226556SLEEVE FOR FIXER GUIDE Ø2.0MM PALATALAFGP 20-5AFGP 20-52026-10-29
07899995226563SLEEVE FOR FIXER GUIDE Ø1.4MMAFG 14-10AFG 14-102026-10-29
07899995234322Organizar Box Beyond Full Arch SurgicalCOBFA 01COBFA 012026-10-29
07899995234339Organizer Box Intraoral Pro Scanning StarterCOIPSSCOIPSS2026-10-29
07899995234346DRIVER RATCHET IMP. MT16° GUIDEDCCMTG 01CCMTG 012026-10-29
07899995234353DRIVER RATCHET IMP. MT16° GUIDED NARROWCCMTG 01ECCMTG 01E2026-10-29
07899995234360DRIVER HANDP. IMP. MT16° GUIDEDCTMTG 01CTMTG 012026-10-29
07899995234377DRIVER HANDP. IMP. MT16° GUIDED NARROWCTMTG 01ECTMTG 01E2026-10-29
07899995234391ANALOG REVERSE MICRO MINI ABUT.ARMMAARMMA2026-10-29
07899995234407ANALOG REVERSE MINI ABUT.ARMAARMA2026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968612008plant Implant System8dent Inc.NHA2026-10-29
088000968612178plant Implant System8dent Inc.NHA2026-10-29
088000968612248plant Implant System8dent Inc.NHA2026-10-29
088000968582488plant Implant System8dent Inc.NHA2026-10-28
088000968583238plant Implant System8dent Inc.NHA2026-10-28
088000968583308plant Implant System8dent Inc.NHA2026-10-28
088000968583548plant Implant System8dent Inc.NHA2026-10-28
088000968583618plant Implant System8dent Inc.NHA2026-10-28
088000968583928plant Implant System8dent Inc.NHA2026-10-28
088000968585218plant Implant System8dent Inc.NHA2026-10-28
088000968585388plant Implant System8dent Inc.NHA2026-10-28
088000968585458plant Implant System8dent Inc.NHA2026-10-28
088000968585698plant Implant System8dent Inc.NHA2026-10-28
088000968585768plant Implant System8dent Inc.NHA2026-10-28
088000968585838plant Implant System8dent Inc.NHA2026-10-28
088000968586068plant Implant System8dent Inc.NHA2026-10-28
088000968586138plant Implant System8dent Inc.NHA2026-10-28
088000968586208plant Implant System8dent Inc.NHA2026-10-28
088000968587508plant Implant System8dent Inc.NHA2026-10-28
088000968601668plant Implant System8dent Inc.NHA2026-10-28
088000968604018plant Implant System8dent Inc.NHA2026-10-28
088000968604258plant Implant System8dent Inc.NHA2026-10-28
088000968604328plant Implant System8dent Inc.NHA2026-10-28
088000968604568plant Implant System8dent Inc.NHA2026-10-28
088000968604638plant Implant System8dent Inc.NHA2026-10-28
088000968650488plant Implant System8dent Inc.NHA2026-10-28
088000968650558plant Implant System8dent Inc.NHA2026-10-28
088000968650628plant Implant System8dent Inc.NHA2026-10-28
08809984971922S-PlantIDIS CO.,LTDNHA2026-10-26
088000968514098plant Implant System8dent Inc.NHA2026-10-23