FDA.reportPublic FDA data

Azure

Primary DI
08435457286295
Brand
Azure
Company
TERRATS MEDICAL SL.
Model
12.044-P10
Catalog number
ARSBL-CAPH41X10
Device description
Conical BL
Published
2024-04-26
Public version status
New
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
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
08435457286295PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435457286295084354572862958435457286295

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure kitA collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+34935646006orders@dessdental.com

Regulatory Flags#

DUNS number
769461323
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08435750447515Azure19.069_02-P10ARMU-SOXTRXX102026-01-15
08435750447522Azure19.093_03-P10ARMU-SOXHX120X102026-01-15
08435750447539Azure19.094_01-P10ARMU-SOXHX122X102026-01-15
08435750447546Azure19.095_04-P10ARMU-SOXHX127X102026-01-15
08435750447553Azure19.096_05-P10ARMU-SOXUGX102026-01-15
08435457271581Keystone19284192842025-06-18
08435457271598Keystone19.284-P519.284-P52025-06-18
08435750431019Azure53.153-P10ODS-SB0102025-06-18
08435750426855Alpha Dent Implants19.097TAAK2025-03-19
08435750426879Alpha Dent Implants16.428TPCK32025-03-19
08435750426886Alpha Dent Implants15.428TPCK3-NH2025-03-19
08435750426893Alpha Dent Implants16.428/2TPCK3_12025-03-19
08435750426909Alpha Dent Implants15.428/2TPCK3_1-NH2025-03-19
08435750426916Alpha Dent Implants16.428/3TPCK3_22025-03-19
08435750426923Alpha Dent Implants15.428/3TPCK3_2-NH2025-03-19
08435750426930Alpha Dent Implants16.438/3TPCK3_32025-03-19
08435750426947Alpha Dent Implants15.438/3TPCK3_3-NH2025-03-19
08435750426954Alpha Dent Implants16.427TPCK3_N2025-03-19
08435750426961Alpha Dent Implants16.427/2TPCK3_N12025-03-19
08435750426978Alpha Dent Implants16.427/3TPCK3_N22025-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03
07630031778437NAInstitut Straumann AGNDP2026-06-03
07630031778444NAInstitut Straumann AGNDP2026-06-03
07630031778475NAInstitut Straumann AGNDP2026-06-03