FDA.report

Neoss Implant System

Primary DI
05060440331107
Brand
Neoss Implant System
Company
Neoss Ltd
Model
31167
Catalog number
31167
Device description
Neoss Hex Adaptor
Published
2015-05-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications

CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060440331107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060440331107050604403311075060440331107

GMDN Terms

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

Regulatory Flags

DUNS number
216693627
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05060440333774Neoss Implant SystemIndividual Abutment, Ti, SSC 2023-12-22
05060440333781Neoss Implant SystemIndividual Abutment, Ti, ASC 2023-12-22
05060440335860Neoss Implant SystemBridge Ti 2023-12-22
05060440335877Neoss Implant SystemBar Ti 2023-12-22
05060440336669Neoss Implant SystemDolder Bar Ti 2023-12-22
05060440335181Neoss Implant System41177411772020-02-24
05060440334924Neoss Implant System64015640152020-02-17
05060440334931Neoss Implant System64019640192020-02-17
05060440330926Neoss Implant System64010640102015-05-29
05060440330933Neoss Implant System64011640112015-05-29
05060440330940Neoss Implant System64012640122015-05-29
05060440330957Neoss Implant System64013640132015-05-29
05060440330964Neoss Implant System64014640142015-05-29
05060440331619Neoss Implant System64020640202015-08-26
05060440331626Neoss Implant System64021640212015-08-26
05060440334986Neoss Implant System51185511852020-01-27
05060440332661Neoss Implant System51150511502015-10-05
05060440332555Neoss Implant System51125511252015-10-05
05060440332081Neoss Implant System41178411782015-10-01
05060440332098Neoss Implant System41179411792015-10-01

Other Devices Sharing Product Codes

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00840481136009LOCATORZest Anchors, LLCDZE2026-05-22
08806395269907ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269914ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395269921ABBA-ST Strong Co., Ltd.DZE2026-05-22
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08806395270019ABBA-ST Strong Co., Ltd.DZE2026-05-22
08806395270026ABBA-ST Strong Co., Ltd.DZE2026-05-22
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088000968507788plant Implant System8dent Inc.DZE2026-03-23
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08800362100088DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100095DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20
08800362100101DIMPLO FixtureDIMPLO Ltd.DZE2026-03-20