FDA.reportPublic FDA data

Metallic Abutment

Primary DI
07899995207937
Brand
Metallic Abutment
Company
Sin Sistema de Implante Nacional S/A
Model
EUCLAM 4504-H
Catalog number
EUCLAM 4504-H
Device description
PLASTIC ABUTMENT CR-CO MORSE Ø 4.5X4MM
Published
2022-07-02
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
K170392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170392000S.I.N. Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.2017-12-01DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899995207937PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995207937078999952079377899995207937

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
07899995243898FIXATION SCREW CM11.5° ANG. MOD BPFCM 01BPFCM 01B2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD APFCM 01APFCM 01A2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BPFMT 01BPFMT 01B2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD APFMT 01APFMT 01A2026-07-22
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGCTA 01ELCTA 01EL2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGCTA 01LCTA 01L2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMCTA 01MCTA 01M2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGCCA 01ELCCA 01EL2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGCCA 01LCCA 01L2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMCCA 01MCCA 01M2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTCCA 01CCCA 01C2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTCCA 01ECCCA 01EC2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGCCER 18LCCER 18L2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMCCER 18MCCER 18M2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTCCER 18CCCER 18C2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGCCER 16LCCER 16L2026-07-14
07899995235565DRIVER RATCHET RETRIVER M1.6MM SHORTCCER 16CCCER 16C2026-07-14
07899995235541RATCHET RETRIEVER DRIVER M1.6 MEDIUMCCER 16MCCER 16M2026-06-23
07899995279668Abutment ScrewPRH 30 PACK4PRH 30 PACK42026-03-13
07899995243805DRIVER RATCHET HEX1.4 EXT. LONG ANG.CCH 1437ACCH 1437A2025-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809918260054LW Narrow Solid AbutmentOssvis Co., Ltd.NHA2026-10-22
08809918260085LW Narrow Solid AbutmentOssvis Co., Ltd.NHA2026-10-22
08809984988135S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988210S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988296S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988333S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988371S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988418S-PlantIDIS CO.,LTDNHA2026-10-22
08809984988456S-PlantIDIS CO.,LTDNHA2026-10-22
08809984987886S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987909S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987923S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987947S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987961S-PlantIDIS CO.,LTDNHA2026-10-21
08809984987985S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988005S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988029S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988043S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988067S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988098S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988173S-PlantIDIS CO.,LTDNHA2026-10-21
08809984988258S-PlantIDIS CO.,LTDNHA2026-10-21
088000968494068plant Implant System8dent Inc.NHA2026-10-20
088000968498338plant Implant System8dent Inc.NHA2026-10-20
088000968514618plant Implant System8dent Inc.NHA2026-10-20
088000968514788plant Implant System8dent Inc.NHA2026-10-20
088000968514858plant Implant System8dent Inc.NHA2026-10-20
088000968515778plant Implant System8dent Inc.NHA2026-10-20
088000968611568plant Implant System8dent Inc.NHA2026-10-20
088000968621608plant Implant System8dent Inc.NHA2026-10-20