FDA.reportPublic FDA data

DYNAMIC ABUTMENT® SOLUTIONS

Primary DI
08436568734446
Brand
DYNAMIC ABUTMENT® SOLUTIONS
Company
TALLADIUM ESPAÑA SL
Model
43.322.316.01-2
Device description
DAS Multi-Unit Screwdriver. 4x4mm L22mm
Published
2026-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08436568734446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436568734446084365687344468436568734446

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+34973289580das@dynamicabutment.com

Regulatory Flags#

DUNS number
510591266
Device count
1
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
08435673516831DYNAMIC ABUTMENT SOLUTIONS53.322.997.01-22026-09-21
08435673515131DYNAMIC ABUTMENT SOLUTIONS54.322.205.31-22026-07-20
08435673516664DYNAMIC ABUTMENT SOLUTIONS49.625.000.01-22026-07-03
08435673512277DYNAMIC ABUTMENT SOLUTIONS35.322.209.21-22026-02-04
08436568733845DYNAMIC ABUTMENT SOLUTIONS42.303.030.01-22026-02-04
08436568733852DYNAMIC ABUTMENT SOLUTIONS42.303.030.02-22026-02-04
08436568733869DYNAMIC ABUTMENT SOLUTIONS42.303.030.03-22026-02-04
08436568733876DYNAMIC ABUTMENT SOLUTIONS42.303.030.04-22026-02-04
08436568733944DYNAMIC ABUTMENT SOLUTIONS42.302.207.01-22026-02-04
08436568733951DYNAMIC ABUTMENT SOLUTIONS42.302.207.02-22026-02-04
08436568733968DYNAMIC ABUTMENT SOLUTIONS42.302.207.03-22026-02-04
08436568733975DYNAMIC ABUTMENT SOLUTIONS42.302.207.04-22026-02-04
08436568734286DYNAMIC ABUTMENT SOLUTIONS42.302.033.01-22026-02-04
08436568734293DYNAMIC ABUTMENT SOLUTIONS42.302.033.02-22026-02-04
08436568734309DYNAMIC ABUTMENT SOLUTIONS42.302.033.03-22026-02-04
08436568734316DYNAMIC ABUTMENT SOLUTIONS42.302.033.04-22026-02-04
08436568734323DYNAMIC ABUTMENT SOLUTIONS42.303.035.01-22026-02-04
08436568734330DYNAMIC ABUTMENT SOLUTIONS42.303.035.02-22026-02-04
08436568734347DYNAMIC ABUTMENT SOLUTIONS42.303.035.03-22026-02-04
08436568734354DYNAMIC ABUTMENT SOLUTIONS42.303.035.04-22026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701045246398KONTACTBIOTECH DENTALNDP2026-10-26
03701045279471KONTACTBIOTECH DENTALNDP2026-10-26
03701045279488KONTACTBIOTECH DENTALNDP2026-10-26
03701045279495KONTACTBIOTECH DENTALNDP2026-10-26
03701045279501KONTACTBIOTECH DENTALNDP2026-10-26
03701045279518KONTACTBIOTECH DENTALNDP2026-10-26
03701045279525KONTACTBIOTECH DENTALNDP2026-10-26
03701045279532KONTACTBIOTECH DENTALNDP2026-10-26
03701045279549KONTACTBIOTECH DENTALNDP2026-10-26
03701045279556KONTACTBIOTECH DENTALNDP2026-10-26
03701045279563KONTACTBIOTECH DENTALNDP2026-10-26
03701045279570KONTACTBIOTECH DENTALNDP2026-10-26
03701045279587KONTACTBIOTECH DENTALNDP2026-10-26
03701045279594KONTACTBIOTECH DENTALNDP2026-10-26
03701045279600KONTACTBIOTECH DENTALNDP2026-10-26
03701045279617KONTACTBIOTECH DENTALNDP2026-10-26
03701045279624KONTACTBIOTECH DENTALNDP2026-10-26
03701045279631KONTACTBIOTECH DENTALNDP2026-10-26
03701045279648KONTACTBIOTECH DENTALNDP2026-10-26
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