FDA.reportPublic FDA data

X-Nav FastMap Scan Body

Primary DI
05712821013231
Brand
X-Nav FastMap Scan Body
Company
Elos Medtech Pinol A/S
Model
XMUA60
Catalog number
XMUA60
Device description
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK).
Published
2024-05-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05712821013217Direct MarkingGS10
05712821013231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05712821013217057128210132175712821013217
05712821013231057128210132315712821013231

GMDN Terms#

Term, Definition table
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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
306155953
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05712821017758Elos Accurate Pre-Milled BlankPMB-NGM45-1PMB-NGM45-12026-03-06
05712821017369Elos Accurate Pre-Milled BlankPMB-NBR35-1PMB-NBR35-12023-06-19
05712821017376Elos Accurate Pre-Milled BlankPMB-NBR43-1PMB-NBR43-12023-06-19
05712821017383Elos Accurate Pre-Milled BlankPMB-SBO33-1PMB-SBO33-12023-06-19
05712821017390Elos Accurate Pre-Milled BlankPMB-SBO41-1PMB-SBO41-12023-06-19
05712821017406Elos Accurate Pre-Milled BlankPMB-ATE36-1PMB-ATE36-12023-06-19
05712821017413Elos Accurate Pre-Milled BlankPMB-ATE42-1PMB-ATE42-12023-06-19
05712821017420Elos Accurate Pre-Milled BlankPMB-NBR50-1PMB-NBR50-12024-01-04
05712821017437Elos Accurate Pre-Milled BlankPMB-NBR60-1PMB-NBR60-12024-01-04
05712821017444Elos Accurate Pre-Milled BlankPMB-NBA30-1PMB-NBA30-12024-01-04
05712821017451Elos Accurate Pre-Milled BlankPMB-NBA35-1PMB-NBA35-12024-01-16
05712821017468Elos Accurate Pre-Milled BlankPMB-NBA43-1PMB-NBA43-12024-01-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03