DEVICE: OrthoEasy® (EFOR1101A23101)
Device Identifier (DI) Information
OrthoEasy®
1101A2310
In Commercial Distribution
Forestadent Bernhard Förster GmbH
1101A2310
In Commercial Distribution
Forestadent Bernhard Förster GmbH
Ortho Easy Pin gold anodized .022" 1,7 x 10 mm (5 pcs.)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
46536 | Orthodontic anchoring screw |
A small, metallic, implantable rod with a spiral thread and slotted/formed head that is inserted into the bone of the jaw to serve as a temporary anchor for an orthodontic device (e.g., a spring or plate). It is available in various sizes and lengths, and may have a self-drilling/self-tapping thread for easy insertion and removal after desired alignment of the teeth. It is used in a variety of orthodontic treatment situations, especially when normal anatomy has been compromised (e.g., due to periodontal disease or agenesis, displacement of teeth in the same direction, asymmetrical anatomy). This is a single-use device.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OAT | Implant, endosseous, orthodontic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K110275 | 000 |
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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No Device Sizes |
Device Record Status
0bbfd914-37a2-40e6-9a78-15efbbd91c31
January 03, 2024
2
August 15, 2019
January 03, 2024
2
August 15, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
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:
EFOR1101A231011
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4972314590
regulatory@forestadent.com
regulatory@forestadent.com