FDA.reportPublic FDA data

Osteon Medical

Primary DI
D102SGKAA0
Brand
Osteon Medical
Company
IMPLANT SOLUTIONS PTY LTD
Model
1
Device description
Scan Gauge Kits are a selection of scan gauges, which are designed to facilitate the acquisition of accurate implant position readings in scans taken with intraoral scanners for full arch prosthetic restorations. The scan gauges are to be mounted directly on the implant abutment embedded in the patient’s mouth using the driver and screws provided in the kit.
Published
2022-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
D102SGKAA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, intraoral-scanning, single-useAn intraoral device intended to be used as a temporary copy of a dental implant abutment for attachment to a final dental implant and/or implant abutment during a scanning procedure to confirm its orientation/position as part of a dental restoration; it may in addition be intended for laboratory scanning. It is typically made of a radiopaque material (e.g., barium sulfate) and may be used in conjunction with an intraoral x-ray sensor. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+61392640111info@osteonmedical.com

Regulatory Flags#

DUNS number
756242111
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D102SGKBC0Osteon Medical12022-12-19
D102SGKBD0Osteon Medical12022-12-19
D102SGKBF20Osteon Medical12024-02-05
D102SGKBG20Osteon Medical12024-02-05
D102SGKBE20Osteon Medical12023-09-11
D102SGKAA20Osteon Medical12022-10-24
D102SCANGAUGEKIT0Osteon Medical12022-07-26
D102BAR0Osteon Medical12022-07-26
D102BARNIOSV10Osteon Medical12023-01-19
D102BARNIOSV20Osteon Medical12023-01-19
D102BARNIOSV30Osteon Medical12023-01-19
D102BARNIOSV40Osteon Medical12023-01-19
D102BRIDGE0Osteon Medical12022-07-26

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Primary DI, Brand, Company table
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