DEVICE: N.A. (J011728507010)

Device Identifier (DI) Information

N.A.
728-507-01
Not in Commercial Distribution

DENTAURUM GmbH & Co.KG
J011728507010
HIBCC
May 24, 2018
1
315427286 *Terms of Use
Titanium lingual retainer acc. to Kimmich, Length 24 mm
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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?
35310 Orthodontic retainer
An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EHO BAR, PREFORMED
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: No special storage conditions required
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Clinically Relevant Size

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

ec2ccf37-e1f8-4e02-b199-27eb8cc243f9
February 05, 2021
5
September 15, 2016
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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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)523-3946
info@dentaurum-us.com
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