DEVICE: OrthoEasy (EFOR1101A2310)
Device Identifier (DI) Information
OrthoEasy
1101A2310
In Commercial Distribution
1101A2310
Forestadent Bernhard Förster GmbH
1101A2310
In Commercial Distribution
1101A2310
Forestadent Bernhard Förster GmbH
The device is intended to provide a fix anchorage point for attachment of orthodontic appliance to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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55772 | Organic solvent metabolite IVD, kit, liquid chromatography |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple metabolites/biomarkers associated with occupational or environmental exposure to volatile organic solvents (e.g., benzene, styrene, toluene, xylene) in a clinical specimen, using a liquid chromatography method. Compounds detected typically include phenol, cresol, hippuric acid, methylhippuric acid, mandelic acid, muconic acid, and/or phenylglyoxylic acid; detection of polycyclic aromatic hydrocarbon (PAH) metabolites is not included.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OAT | Implant, Endosseous, Orthodontic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Length: 10 Millimeter |
Device Record Status
bba74f4e-86d6-4c32-ad44-aa750fffaba6
October 31, 2018
4
September 16, 2015
October 31, 2018
4
September 16, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined