FDA.reportPublic FDA data

KLOCKNER

Primary DI
08435451646552
Brand
KLOCKNER
Company
SOADCO, S.L.
Model
18 10 25
Catalog number
18 10 25
Device description
VEGA NV Ti-BASE ABUTMENT [U-AT1.5-AP5]
Published
2025-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K170022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170022000Klockner Vega TiBase for CERECSOADCO, S.L.2017-11-16NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435451646552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435451646552084354516465528435451646552

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
+376800593calidad@soadco.com

Regulatory Flags#

DUNS number
464517122
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
08435451648037KLOCKNER20 51 0120 51 012025-02-18
08435451648044KLOCKNER20 51 0220 51 022025-02-18
08435451648051KLOCKNER20 51 0320 51 032025-02-18
08435451648068KLOCKNER20 51 0420 51 042025-02-18
08435451648075KLOCKNER20 51 0520 51 052025-02-18
08435451648082KLOCKNER20 51 0620 51 062025-02-18
08435451648099KLOCKNER20 51 0720 51 072025-02-18
08435451648105KLOCKNER20 51 0820 51 082025-02-18
08435451648112KLOCKNER20 51 0920 51 092025-02-18
08435451648129KLOCKNER20 51 1020 51 102025-02-18
08435451648136KLOCKNER20 51 1120 51 112025-02-18
08435451648143KLOCKNER20 51 1220 51 122025-02-18
08435451648150KLOCKNER20 51 1320 51 132025-02-18
08435451648167KLOCKNER20 51 1420 51 142025-02-18
08435451648174KLOCKNER20 51 1520 51 152025-02-18
08435451648181KLOCKNER20 51 1620 51 162025-02-18
08435451648198KLOCKNER20 51 1720 51 172025-02-18
08435451648204KLOCKNER20 51 1820 51 182025-02-18
08435451648211KLOCKNER20 51 1920 51 192025-02-18
08435451648228KLOCKNER20 51 2020 51 202025-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114711548prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-13
07290114711630prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-13
07290114712491prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-13
00842448118608TITAN IMPLANTS INCTITAN IMPLANT INCNHA2026-10-12
07290114710039Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710046prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710114prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710138prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710145prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710312Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
07290114710732Indirect Transfer 13mm open trayCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-11
08809984989040S-PlantIDIS CO.,LTDNHA2026-10-07
07290114712675prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712682prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712699prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712705prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712712prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712729prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712736prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712743prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
07290114712750prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNHA2026-10-07
08809984970895S-PlantIDIS CO.,LTDNHA2026-10-07
08809984981518S-PlantI Dis Co., Ltd.NHA2026-10-07
D7702764233TRANSGINGIVAL HEALING CAP H3MMSWEDEN & MARTINA SPANHA2026-10-07
D7702764243TRANSGINGIVAL HEALING CAP H5MMSWEDEN & MARTINA SPANHA2026-10-07
05712821014696Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014702Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014719Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014726Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06
05712821014733Elos Accurate Hybrid Base G EngagingElos Medtech Pinol A/SNHA2026-10-06