DEVICE: PEDO-ADAPTABLE CLASS III MASK (D7751551210)

Device Identifier (DI) Information

PEDO-ADAPTABLE CLASS III MASK
155-121
In Commercial Distribution
155-121
GREAT LAKES ORTHODONTICS, LTD.
D7751551210
HIBCC

1
041854332 *Terms of Use
PEDO-ADAPTABLE CLASS III MASK
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Orthodontic extraoral headgear A dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is fastened to the orthodontic appliance in the patient's mouth, or utilizes rests on the chin and forehead (reverse pull headgear).
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FDA Product Code

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Product Code Product Code Name
DZB Headgear, Extraoral, Orthodontic
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K861424 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

573c9dba-c892-4693-a24d-27ca00e8d6d4
July 06, 2018
3
May 18, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

[?]
No
No
No
Yes
No CLOSE

Customer Contact

[?]
8008287626
info@greatlakesortho.com
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