FDA.reportPublic FDA data

SDS1.2/ SDS2.2

Primary DI
04260468254261
Brand
SDS1.2/ SDS2.2
Company
SDS Swiss Dental Solutions AG
Model
SDS-SD-ST
Device description
SDS1.2/2.2 screwdriver
Published
2020-08-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
04260468254261PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260468254261042604682542614260468254261

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

Contacts#

Phone, Email table
PhoneEmail
(774) 634-6225info.us@swissdentalsolutions.com

Regulatory Flags#

DUNS number
487103033
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260468254858SDS Insertion tool removerSDS_ITR2025-11-28
04260468254278SDS1.2/ SDS2.2SDS-SD_short-ST2020-08-05
04260468250164SDS1.2SDS1.2_PC_3.8-P2020-08-05
04260468250171SDS1.2SDS1.2_PC_4.6-P2020-08-05
04260468250256SDS2.2SDS2.2_54082020-08-05
04260468250508SDS1.2SDS1.2_4611-ov_6x82020-08-05
04260468250645SDS1.2SDS1.2_4614-ov_6x82020-08-05
04260468250652SDS2.2SDS2.2_4611-ov_6x82020-08-05
04260468250669SDS2.2SDS2.2_4614-ov_6x82020-08-05
04260468250676SDS2.2SDS2.2_HC-disc-6x92020-08-05
04260468251192SDS1.2SDS1.2_33142020-08-05
04260468251208SDS1.2SDS1.2_38082020-08-05
04260468251215SDS1.2SDS1.2_38112020-08-05
04260468251222SDS1.2SDS1.2_38142020-08-05
04260468251239SDS1.2SDS1.2_46082020-08-05
04260468251246SDS1.2SDS1.2_46112020-08-05
04260468251253SDS1.2SDS1.2_46142020-08-05
04260468251260SDS1.2SDS1.2_54112020-08-05
04260468251277SDS1.2SDS1.2_54142020-08-05
04260468251284SDS2.2SDS2.2_38082020-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07392532032349Bone TrapDentsply Implants Manufacturing GmbHNDP2026-10-16
06009544052913N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-14
08809918259713LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
08809918259720LW OSS Abutment Lab AnalogOssvis Co., Ltd.NDP2026-10-13
03700977513110SlimEUROTEKNIKANDP2026-10-12
03700977513363iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513370iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513387iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513394iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513400iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513417iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513424iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513431iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513448iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513455iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513462iFlag ReversoEUROTEKNIKANDP2026-10-12
03700977513639iFlag ReversoEUROTEKNIKANDP2026-10-12
07290116661322Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-10-11
00810157315762MUA PEEK Comfort CapParagon Implant Mfg., LLCNDP2026-10-09
06942799001100SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-10-09
07899878068143NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068150NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068167NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
07899878068174NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-10-09
06009544052876N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052883N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052890N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052906N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052920N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07
06009544052937N/ASOUTHERN IMPLANTS (PTY) LTDNDP2026-10-07