EK 30° Multi Angled abutment

Primary DI
00810125998683
Brand
EK 30° Multi Angled abutment
Company
HIOSSEN, INC.
Model
EK30MA4850TH
Published
2026-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K251427000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251427000EK MULTI ANGLED 30 ABUTMENTHiossen, Inc.2026-01-29NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810125998683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810125998683008101259986838101259986830810125998683

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, single-useA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
796083090
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810126045911ET IV Fixture Ultra-Wide NH Regular Pre-MountedAET4R6015B2026-04-10
00810126045294ET IV Fixture NH Regular Pre-MountedAET4M3508B2026-04-07
00810126045300ET IV Fixture SA Regular Pre-MountedAET4M3508S2026-04-07
00810126045317ET IV Fixture NH Regular Pre-MountedAET4M3510B2026-04-07
00810126045324ET IV Fixture SA Regular Pre-MountedAET4M3510S2026-04-07
00810126045331ET IV Fixture NH Regular Pre-MountedAET4M3511B2026-04-07
00810126045348ET IV Fixture SA Regular Pre-MountedAET4M3511S2026-04-07
00810126045355ET IV Fixture NH Regular Pre-MountedAET4M3513B2026-04-07
00810126045362ET IV Fixture SA Regular Pre-MountedAET4M3513S2026-04-07
00810126045379ET IV Fixture NH Regular Pre-MountedAET4M3515B2026-04-07
00810126045386ET IV Fixture SA Regular Pre-MountedAET4M3515S2026-04-07
00810126045393ET IV Fixture NH Regular Pre-MountedAET4R4007B2026-04-07
00810126045409ET IV Fixture SA Regular Pre-MountedAET4R4007S2026-04-07
00810126045416ET IV Fixture NH Regular Pre-MountedAET4R4008B2026-04-07
00810126045423ET IV Fixture SA Regular Pre-MountedAET4R4008S2026-04-07
00810126045430ET IV Fixture NH Regular Pre-MountedAET4R4010B2026-04-07
00810126045447ET IV Fixture SA Regular Pre-MountedAET4R4010S2026-04-07
00810126045454ET IV Fixture NH Regular Pre-MountedAET4R4011B2026-04-07
00810126045461ET IV Fixture SA Regular Pre-MountedAET4R4011S2026-04-07
00810126045478ET IV Fixture NH Regular Pre-MountedAET4R4013B2026-04-07

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Primary DI, Brand, Company table
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