FDA.reportPublic FDA data

DYNAMIC ABUTMENT SOLUTIONS

Primary DI
08435673507891
Brand
DYNAMIC ABUTMENT SOLUTIONS
Company
TALLADIUM ESPAÑA SL
Model
75.117.084.48-2
Device description
Implant Mount Offset 9mm. Comp.0084-B1
Published
2023-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
08435673507891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435673507891084356735078918435673507891

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant holding endpieceA device intended to hold a dental implant (e.g., orthodontic implant screw) at its distal end during the application of the implant to the patient’s oral cavity. It is typically a small metal shaft designed to be mounted onto the distal end of a manual screwdriver or slow-speed power tool whereby rotation is applied to introduce the implant into a surgical cavity. 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
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
08436568734651DYNAMIC ABUTMENT SOLUTIONS42.302.006.01-22026-02-04
08436568734668DYNAMIC ABUTMENT SOLUTIONS42.302.006.02-22026-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013189MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013229MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013239MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013289MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013369MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013379MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013389MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013399MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013509MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013599MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013609MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013619MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013769MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA013829MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA019019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA021029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA023029MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028129MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028139MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028209MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA028219MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031019MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031049MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
EMKA031059MEDENTiKAMEDENTiKA GmbHNDP2020-04-08