FDA.reportPublic FDA data

EK III NH Fixture No Mount

Primary DI
00810126040312
Brand
EK III NH Fixture No Mount
Company
HIOSSEN, INC.
Model
CEK3S7010B
Published
2024-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240232000EK D3.3 and Ultra Wide ImplantsHiossen, Inc.2024-09-13DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810126040312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810126040312008101260403128101260403120810126040312

GMDN Terms#

Term, Definition table
TermDefinition
Screw endosteal dental implant, two-pieceA sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.

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
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814913024219A-Oss®AOSN010SV2016-09-30
00814913024226A-Oss®AOSN025SV2016-09-30
00814913024233A-Oss®AOSN050SV2016-09-30
00814913024240A-Oss®AOSN100SV2016-09-30
00814913024257A-Oss®AOSN200SV2016-09-30
00814913024264A-Oss®AOSN010LV2016-09-30
00814913024271A-Oss®AOSN025LV2016-09-30
00814913024288A-Oss®AOSN050LV2016-09-30
00814913024295A-Oss®AOSN100LV2016-09-30
00814913024301A-Oss®AOSN200LV2016-09-30
00814913024974A-graft®[Bone grafting material,Animal source]HAS010SV2018-04-27
00814913024981A-graft®[Bone grafting material,Animal source]HAS025SV2018-04-27
00814913024998A-graft®[Bone grafting material,Animal source]HAS050SV2018-04-27
00814913025001A-graft®[Bone grafting material,Animal source]HAS100SV2018-04-27
00814913025018A-Oss®A-graft®[Bone grafting material,Animal source]HAS200SV2018-04-27
00814913025025A-graft®[Bone grafting material,Animal source]HAS010LV2018-04-27
00814913025032A-graft®[Bone grafting material,Animal source]HAS025LV2018-04-27
00814913025049A-graft®[Bone grafting material,Animal source]HAS050LV2018-04-27
00814913025056A-graft®[Bone grafting material,Animal source]HAS100LV2018-04-27
00814913025063A-graft®[Bone grafting material,Animal source]HAS200LV2018-04-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290114710756prosthetics - TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710787prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710800prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710831prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114710848prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114711654prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114711661prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712026prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712170prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712651prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114712668prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114713054prosthetics -TransferCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114713429prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114713948prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
07290114714570prosthetics -Cover screwCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-14
D7702764603PRAMA WHITE IMPLANT ZIRTISWEDEN & MARTINA SPADZE2026-10-14
D7702764613PRAMA WHITE IMPLANT ZIRTISWEDEN & MARTINA SPADZE2026-10-14
07290114711548prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-13
07290114711630prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-13
07290114712491prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-13
07290114710039Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710046prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710114prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710138prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710145prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710312Abutments Prosthetic AccessoriesCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114710732Indirect Transfer 13mm open trayCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-11
07290114712675prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712682prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07
07290114712699prosthetics - Long Term abutmentsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDDZE2026-10-07