FDA.reportPublic FDA data

KLOCKNER

Primary DI
08435451628534
Brand
KLOCKNER
Company
SOADCO, S.L.
Model
84 01 25-2
Catalog number
84 01 25-2
Device description
EC G 25° MEDPROTIBASE ABUTMENT [M-AT0.5-A1] MP360
Published
2023-06-13
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
K230103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230103000Klockner AbutmentsSOADCO, S.L.2023-04-24NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435451628534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435451628534084354516285348435451628534

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

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Primary DI, Brand, Company table
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08800075208620Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
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08800075208712Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08800075208729Oneday Mini Implant SystemOneday Biotech Co.,Ltd.NHA2026-06-04
08435389830764MULTI-IM® HEALING CAP, TINY® & UNIVERSAL PLATFORM L:3 mmBIOTECHNOLOGY INSTITUTE SLNHA2026-05-27
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