FDA.reportPublic FDA data

Intraoral Pro Scanning Starter Kit

Primary DI
07899995237736
Brand
Intraoral Pro Scanning Starter Kit
Company
Sin Sistema de Implante Nacional S/A
Model
KIPSS
Catalog number
KIPSS
Device description
Intraoral Pro Scanning Starter Kit
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899995237736PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899995237736078999952377367899995237736

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
904569092
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
00385640095372INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095389INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095396INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095402INSTRUSAFESummit Medical, Inc.KCT2026-10-29
07899995223999ORGANIZER BOX VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234322Organizar Box Beyond Full Arch SurgicalSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234339Organizer Box Intraoral Pro Scanning StarterSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237705Organizer Box Intraoral Pro Scanning PremiumSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237712Beyond Full Arch Surgical KitSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237729Intraoral Pro Scanning Premium KitSin Sistema de Implante Nacional S/AKCT2026-10-29
00385640095341INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095358INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095365INSTRUSAFESummit Medical, Inc.KCT2026-10-28
07899995224002SURGICAL KIT VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-28
G476ISTO20X10X2ISTO BIOLOGICS SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-27
00385640095327INSTRUSAFESummit Medical, Inc.KCT2026-10-26
00385640095334INSTRUSAFESummit Medical, Inc.KCT2026-10-26
03701045278962KONTACTBIOTECH DENTALKCT2026-10-26
03701045278979KONTACTBIOTECH DENTALKCT2026-10-26
06973993446022Sterilization CassetteAlliedstar Medical Equipment Co., Ltd.KCT2026-10-26
00385640095303INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00385640095310INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00642356006673Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006680Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006697Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006703Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006710Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006734Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006758Mastel SurgicalMastel Surgical Inc.KCT2026-10-23
00642356006765Mastel SurgicalMastel Surgical Inc.KCT2026-10-23