FDA.reportPublic FDA data

Straight abutment wide with shoulder

Primary DI
07290018434581
Brand
Straight abutment wide with shoulder
Company
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
Model
2mm
Catalog number
SAW2
Published
2024-01-24
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
K191443000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191443000MSDI Dental Implants SystemMedical Systems and Devices International , Ltd.2020-06-26DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018434581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018434581072900184345817290018434581

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant systemA collection of devices designed for the surgical placement of a dental implant 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 typically consists of a sterile endosteal dental implant (implant body and abutment) and surgical instruments for implantation.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
531825934
Device count
1
Lot or batch
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
07290019897620Ratchet click driver longRPRPRCDL2024-01-30
07290019897675Implant hand driver shortALIHDS2024-01-30
07290019897019Implant hand driver longRPRPIHDL2024-01-29
07290019897026Motor mount click driver longTPTPMCDL2024-01-29
07290019897071Motor mount click driver short NPNPMCDS2024-01-29
07290019897125Motor mount click driver longNPNPMCDL2024-01-29
07290019897156Guided ratchet driver longALGDRIML2024-01-29
07290019897170Motor mount click driver short RPRPMCDS2024-01-29
07290019897200Guided ratchet driver shortALGDRIMS2024-01-29
07290019897224Motor mount click driver longRPRPMCDL2024-01-29
07290019897255Guided ratchet driver longTPGTPDRIML2024-01-29
07290019897279Ratchet click driver shortALRCDS2024-01-29
07290019897309Guided ratchet driver shortTPGTPDRIMS2024-01-29
07290019897323Ratchet click driver longALRCDL2024-01-29
07290019897354Guided Ti SleeveAL TPGDSS2024-01-29
07290019897378Ratchet click driver shortTPTPRCDS2024-01-29
07290019897385Implant Drivers for Motor long 28mmAlefDMIL2024-01-29
07290019897408Guided Fixation pinsAL TPGDFIX2024-01-29
07290019897422Ratchet click driver longTPTPRCDL2024-01-29
07290019897439Implant Drivers for Motor short 22mmAlefDMIS2024-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290112853103NAUNIQA DENTAL LTDNHA2026-07-19
07290112854148NAUNIQA DENTAL LTDNHA2026-07-19
07290112854407NAUNIQA DENTAL LTDNHA2026-07-19
07290112854414NAUNIQA DENTAL LTDNHA2026-07-19
07290112855138NAUNIQA DENTAL LTDNHA2026-07-19
07290112855145NAUNIQA DENTAL LTDNHA2026-07-19
07290112855152NAUNIQA DENTAL LTDNHA2026-07-19
07290112855169NAUNIQA DENTAL LTDNHA2026-07-19
07290112855749NAUNIQA DENTAL LTDNHA2026-07-19
07290112855756NAUNIQA DENTAL LTDNHA2026-07-19
07290112855763NAUNIQA DENTAL LTDNHA2026-07-19
07290112855770NAUNIQA DENTAL LTDNHA2026-07-19
07290112856692NAUNIQA DENTAL LTDNHA2026-07-19
07290112857637NAUNIQA DENTAL LTDNHA2026-07-19
07290118030003NAUNIQA DENTAL LTDNHA2026-07-19
07290118030010NAUNIQA DENTAL LTDNHA2026-07-19
07290118177333NAUNIQA DENTAL LTDNHA2026-07-19
07290118177340NAUNIQA DENTAL LTDNHA2026-07-19
07290118177357NAUNIQA DENTAL LTDNHA2026-07-19
07290118177364NAUNIQA DENTAL LTDNHA2026-07-19
07290118177371NAUNIQA DENTAL LTDNHA2026-07-19
07290118177388NAUNIQA DENTAL LTDNHA2026-07-19
07290118177395NAUNIQA DENTAL LTDNHA2026-07-19
07290118177425NAUNIQA DENTAL LTDNHA2026-07-19
07290118177432NAUNIQA DENTAL LTDNHA2026-07-19
07290118177449NAUNIQA DENTAL LTDNHA2026-07-19
07290118177456NAUNIQA DENTAL LTDNHA2026-07-19
00842092184301PreatPreat CorporationNHA2025-12-22
00842092184370PreatPreat CorporationNHA2025-12-22
00842092185391PreatPreat CorporationNHA2025-12-22