DEVICE: OrthoEasy® (EFOR1101A23101)

Device Identifier (DI) Information

OrthoEasy®
1101A2310
In Commercial Distribution

Forestadent Bernhard Förster GmbH
EFOR1101A23101
HIBCC

5
316074384 *Terms of Use
Ortho Easy Pin gold anodized .022" 1,7 x 10 mm (5 pcs.)
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Device Characteristics

Labeling does not contain MRI Safety Information
No
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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
OAT Implant, endosseous, orthodontic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K110275 000
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

0bbfd914-37a2-40e6-9a78-15efbbd91c31
January 03, 2024
2
August 15, 2019
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: EFOR1101A231011 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+4972314590
regulatory@forestadent.com
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