FDA.report

Azure

Primary DI
08435457283911
Brand
Azure
Company
TERRATS MEDICAL SL.
Model
14.097
Catalog number
ARNRT-SA6
Device description
Tri-lobe
Published
2023-09-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08435457283911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08435457283911084354572839118435457283911

GMDN Terms

TermDefinition
Dental implant abutment analog, laboratoryA rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+34935646006orders@dess-abutments.com

Regulatory Flags

DUNS number
769461323
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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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

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