FDA.reportPublic FDA data

JIG OF SCAN. HI Ø4.5MM

Primary DI
07899995275127
Brand
JIG OF SCAN. HI Ø4.5MM
Company
Sin Sistema de Implante Nacional S/A
Model
JBHI 45
Catalog number
JBHI 45
Device description
JIG OF SCAN. HI Ø4.5MM
Published
2023-09-04
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
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899995275127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995275127078999952751277899995275127

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment impression capA small device intended to be placed intraorally on the abutment head of a dental implant during a dental impression to facilitate removal of the impression material once it has hardened, and to reproduce the intraoral position and orientation of the abutment/implant in a dental laboratory working model, for the fabrication of a final dental prosthesis (e.g., denture). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
07899995243812DRIVER RATCHET HEX1.4 LONG ANG.CCH 1430ACCH 1430A2025-12-23
07899995243829DRIVER RATCHET HEX1.4 MEDIUM ANG.CCH 1424ACCH 1424A2025-12-23
07899995243836DRIVER RATCHET HEX1.4 SHORT ANG.CCH 1420ACCH 1420A2025-12-23
07899995243843DRIVER HANDP. HEX.1.4MM EXT. LONG ANG.CTH 1437ACTH 1437A2025-12-23
07899995243850DRIVER HANDPIECE HEX.1.4MM LONG ANG.CTH 1430ACTH 1430A2025-12-23
07899995243874DRIVER HANDPIECE HEX.1.4MM MEDIUM ANG.CTH 1424ACTH 1424A2025-12-23
07899995243881DRIVER HANDPIECE HEX.1.4MM SHORT ANG.CTH 1420ACTH 1420A2025-12-23
07899995240507DIRECTION INDICATOR ANGLED 52°IDA 52IDA 522025-11-26
07899995241108BioHorizonsZPK4500ZPK45002025-11-25
07899995243140BioHorizonsZPMDZPMD2025-11-25
07899995243157BioHorizonsZDPZDP2025-11-25
07899995243164BioHorizonsSTW80STW802025-11-25
07899995243225BioHorizonsHD050RHD050R2025-11-25
07899995243232BioHorizonsHD050MHD050M2025-11-25
07899995243263BioHorizonsHD050HHD050H2025-11-25
07899995243270BioHorizonsCRTRY60CRTRY602025-11-25
07899995243287BioHorizonsCRTRY52CRTRY522025-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDNDP2026-07-09
08800313235753SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235760SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235777SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235784SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235791SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235807SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235814SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235821SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235838SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235845SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235852SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235869SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235876SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235883SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235890SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235906SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235913SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235920SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235937SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235944SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235951SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235968SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235975SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235982SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313235999SQ AXEL Guide Step DrillDENTIS CO. ,LTDNDP2026-07-09
08800313236002SQ Guide Long DrillDENTIS CO. ,LTDNDP2026-07-09