FDA.reportPublic FDA data

HM Implant Narrow Ridge

Primary DI
00814913022543
Brand
HM Implant Narrow Ridge
Company
HIOSSEN, INC.
Model
HMN2510R04
Published
2015-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K080594000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080594000MS SYSTEM (NARROW RIDGE)Osstem Implant Co., Ltd.2008-09-03DZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814913022543PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814913022543008149130225438149130225430814913022543

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
10841307136378Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136385Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136392Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136408Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
10841307136415Simply Iconic™ ImplantIMPLANT DIRECT SYBRON MANUFACTURING LLCDZE2026-10-26
08809984970284S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970291S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970307S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970314S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970345S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970352S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970369S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970376S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970390S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970406S-PlantIDIS CO.,LTDDZE2026-10-21
08809984970000S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970017S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970024S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970031S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970048S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970055S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970062S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970079S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970086S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970093S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970109S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970116S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970123S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970130S-PlantIDIS CO.,LTDDZE2026-10-20
08809984970147S-PlantIDIS CO.,LTDDZE2026-10-20