FDA.report

Elos Accurate® Scan Body

Primary DI
05712821005137
Brand
Elos Accurate® Scan Body
Company
Elos Medtech Pinol A/S
Model
IO 8A-B
Catalog number
N/a
Device description
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Published
2020-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05712821008985Direct MarkingGS10
05712821005137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05712821008985057128210089855712821008985
05712821005137057128210051375712821005137

GMDN Terms

TermDefinition
Dental implant suprastructure, temporary, preformed, reusableA 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 includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
306155953
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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05712821017475Elos Accurate Pre-Milled BlankPMB-NBA60-1PMB-NBA60-12024-01-04
05712821017482Elos Accurate Pre-Milled BlankPMB-BRA41-1PMB-BRA41-12024-01-04
05712821017499Elos Accurate Pre-Milled BlankPMB-BRA35-1PMB-BRA35-12024-01-04
05712821017505Elos Accurate Pre-Milled BlankPMB-BRA51-1PMB-BRA51-12024-01-04
05712821017512Elos Accurate Pre-Milled BlankPMB-ATO35-1PMB-ATO35-12024-01-04
05712821017529Elos Accurate Pre-Milled BlankPMB-ATO45-1PMB-ATO45-12024-01-04
05712821017536Elos Accurate Pre-Milled BlankPMB-ATE48-1PMB-ATE48-12024-01-04
05712821017543Elos Accurate Pre-Milled BlankPMB-ATE54-1PMB-ATE54-12024-01-04

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