FDA.reportPublic FDA data

DYNAMIC ABUTMENT® SOLUTIONS

Primary DI
08436568731872
Brand
DYNAMIC ABUTMENT® SOLUTIONS
Company
TALLADIUM ESPAÑA SL
Model
41.320.048.01-2
Device description
Dynamic Screw M2 L4.8mm 25Ncm
Published
2022-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K162021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K1620210003.0 Dynamic TiBaseTalladium Espana, SL2018-05-04NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436568731872PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436568731872084365687318728436568731872

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
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
08436568734446DYNAMIC ABUTMENT® SOLUTIONS43.322.316.01-22026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126046888EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
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00810126046901EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046918EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046925EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046932EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046949EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046956EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046963EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046970EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046987EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126046994EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047007EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047014EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047021EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047038EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047045EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047052EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
00810126047069EK MULTI ANGLED ABUTMENTHIOSSEN, INC.NHA2026-07-31
07392532281730ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
07392532281747ATLANTIS®DENTSPLY IH, INC.NHA2026-07-29
08809917132710Healing Abutment SystemOsstem Implant Co., Ltd.NHA2026-07-29
08800070223673Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
08800070223710Free Milling AbutmentIzenimplant Co., Ltd.NHA2026-07-27
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08800070224311Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27
08800070224359Free Milling Abutment [Abutment + Screw]Izenimplant Co., Ltd.NHA2026-07-27