FDA.reportPublic FDA data

DYNAMIC ABUTMENT SOLUTIONS

Primary DI
08436568733845
Brand
DYNAMIC ABUTMENT SOLUTIONS
Company
TALLADIUM ESPAÑA SL
Model
42.303.030.01-2
Device description
DAS Straight Multi-Unit G1 Comp.0030 30N.cm
Published
2026-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

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
K243732000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243732000Multi-Unit DAS SystemTalladium España, SL2026-01-29NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436568733845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436568733845084365687338458436568733845

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis/implant abutment screwA device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use 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
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
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
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
08436568734446DYNAMIC ABUTMENT® SOLUTIONS43.322.316.01-22026-02-04
08436568734651DYNAMIC ABUTMENT SOLUTIONS42.302.006.01-22026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995243898FIXATION SCREW CM11.5° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243904FIXATION SCREW CM11.5° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243928PARAF. DE FIXACAO MT16° ANG. MOD BSin Sistema de Implante Nacional S/ANHA2026-07-22
07899995243935PARAF. DE FIXACAO MT16° ANG. MOD ASin Sistema de Implante Nacional S/ANHA2026-07-22
08806388266173ZrGEN AbutmentMegagen Implant Co. LtdNHA2024-01-31
08806388244812ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244829ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244836ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244843ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244850ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244867ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244874ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244898ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244904ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244911ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244928ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244935ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244942ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244959ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388244966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256624ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256631ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256648ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388256655ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260690ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260706ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260737ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260744ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260966ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22
08806388260973ZrGEN AbutmentMegagen Implant Co. LtdNHA2023-06-22