FDA.reportPublic FDA data

Azure

Primary DI
08435750411493
Brand
Azure
Company
TERRATS MEDICAL SL.
Model
TPINBL28
Catalog number
ASTBL-DG28
Device description
Conical BL
Published
2024-07-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EILGAUGE, DEPTH, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EILGauge, Depth, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435750411493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435750411493084357504114938435750411493

GMDN Terms#

Term, Definition table
TermDefinition
Dental torque wrenchA hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial marker (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable 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
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#

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
D9098000661ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
D9098000671ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
D9098000681ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
D909800081C1ORTHO ARCHOrtho Arch Company IncEIL2025-09-15
00842092186626PreatPreat CorporationEIL2025-09-05
D9098000341ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980008114ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980013716ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980013918ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
D90980014010ORTHO ARCHOrtho Arch Company IncEIL2025-08-27
00194613114893MSI Precision Specialty InstrumentsMed Saver, Inc.EIL2025-08-01
E8961732150SCHWERTA. Schweickhardt GmbH & Co. KGEIL2025-04-07
EZPF2474408HZU0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEIL2025-03-07
00371347018318Advance Dental ProductsThe Atlanta Dental Supply CompanyEIL2025-01-02
00371347018356Advance Dental ProductsThe Atlanta Dental Supply CompanyEIL2025-01-02
00841336121584Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIL2024-12-11
00190730084682Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084811Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084828Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084835Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084842Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
00190730084859Ortho TechnologyORTHO TECHNOLOGY, INC.EIL2024-09-18
08800016113303Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016113488Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121612Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121629Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121636Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121643Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121650Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08
08800016121667Dental InstrumentCowellmedi Co.,LtdEIL2024-08-08