FDA.reportPublic FDA data

SDS1.2/ SDS2.2

Primary DI
04260468252199
Brand
SDS1.2/ SDS2.2
Company
SDS Swiss Dental Solutions AG
Model
SDS2.0_CS-600+
Device description
Countersink drill for class III 5.4
Published
2020-08-06
Public version status
New
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
04260468252199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260468252199042604682521994260468252199

GMDN Terms#

Term, Definition table
TermDefinition
Ceramic dental burA rotary cutting device, the working end of which is made from ceramic, designed to fit into a dental handpiece that provides the rotation allowing the user to cut hard structures in the mouth, such as teeth and bone. It is available in various shapes (e.g., cylinder, disk, sphere, oval). This is a reusable device.

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
04260468254261SDS1.2/ SDS2.2SDS-SD-ST2020-08-05
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

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Primary DI, Brand, Company table
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08059224218335OT EQUATORRHEIN 83 SRLNDP2026-08-27
08059224218700OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08059224218717OT EQUATOR-OT BRIDGERHEIN 83 SRLNDP2026-08-27
08800131092064DenQ Sub Multi-unit Pick-up Impression copingDenQ Co.,Ltd.NDP2026-08-25
08800131098264DenQ Sub Multi-unit Lab AnalogDenQ Co.,Ltd.NDP2026-08-25
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08800313235449Guide Anchor PinDENTIS CO. ,LTDNDP2026-08-19
08800313235456Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235463Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235470Guide Bone AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235487Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235494Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
08800313235500Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
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08800313235562Guide Fixture AnchorDENTIS CO. ,LTDNDP2026-08-19
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