FDA.reportPublic FDA data

Straight abutment with shoulder

Primary DI
07290018434529
Brand
Straight abutment with shoulder
Company
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD
Model
2mm
Catalog number
SA2
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
07290018434529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018434529072900184345297290018434529

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
07899878068181NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068198NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068211NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068228NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068235NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068242NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07899878068259NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NHA2026-09-25
07392532151156Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532151163Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192425Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192449Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192456Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192463Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192470Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532192487Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNHA2025-10-17
07392532186622N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532186639N/ADentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216343ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216350ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216367ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216374ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216381ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216398ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216404ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216411ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216428ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216435ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216442ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216459ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18
07392532216466ANKYLOS®Dentsply Implants Manufacturing GmbHNHA2020-11-18