FDA.reportPublic FDA data

Neoss Implant System

Primary DI
05060440331190
Brand
Neoss Implant System
Company
Neoss AB
Model
31216
Catalog number
31216
Device description
Access Abutment 4.0 mm
Published
2015-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
K081851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081851000NEOSS ACCESS ABUTMENTSNeoss, Ltd.2009-03-02NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060440331190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060440331190050604403311905060440331190

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
509583543
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060440335532Neoss Implant System64080640802023-02-13
05060440335549Neoss Implant System64081640812023-02-13
05060440335556Neoss Implant System64082640822023-02-13
05060440335563Neoss Implant System64083640832023-02-13
05060440334283Neoss Implant System64036640362020-11-27
05060440334290Neoss Implant System64037640372020-11-27
05060967630226Yomi One Implant System54001540012024-02-15
05060967630233Yomi One Implant System54002540022024-02-15
05060967630004Yomi One Implant System24008240082024-02-15
05060967630011Yomi One Implant System24009240092024-02-15
05060967630028Yomi One Implant System24010240102024-02-15
05060967630035Yomi One Implant System24011240112024-02-15
05060967630042Yomi One Implant System24012240122024-02-15
05060967630059Yomi One Implant System24014240142024-02-15
05060967630066Yomi One Implant System24015240152024-02-15
05060967630073Yomi One Implant System24016240162024-02-15
05060967630080Yomi One Implant System24017240172024-02-15
05060967630097Yomi One Implant System24018240182024-02-15
05060967630103Yomi One Implant System24020240202024-02-15
05060967630110Yomi One Implant System24021240212024-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516877992SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
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04260516878029SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878036SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878043SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878050SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878067SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878074SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878081SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878098SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878104SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878111SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878128SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878135SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
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04260516878159SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878166SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878173SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
04260516878180SIC invent Dental Implant SystemsSIC invent AGNHA2026-08-18
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