FDA.reportPublic FDA data

Strong SW

Primary DI
07899995270900
Brand
Strong SW
Company
Sin Sistema de Implante Nacional S/A
Model
SWHE 3585
Catalog number
SWHE 3585
Device description
IMPLANT STRONG SW HE Ø3,5 X 8,5MM
Published
2022-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

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
07899995270900PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995270900078999952709007899995270900

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, one-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted 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 is a one-piece device composed of an anchorage portion (implant body) in the form of a threaded screw that is implanted into bone, and a retention portion (implant abutment) that protrudes through gingival tissues to support the prosthesis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
904569092
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
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
10841307136378Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136385Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136392Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136408Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136415Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
08809984970284S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970291S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970307S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970314S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970345S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970352S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970369S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970376S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970390S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970406S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970000S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970017S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970024S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970031S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970048S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970055S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970062S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970079S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970086S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970123S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20