DEVICE: BIOCRYL ICE 1QT MONOMER (D7750470060)

Device Identifier (DI) Information

BIOCRYL ICE 1QT MONOMER
047-006
In Commercial Distribution

GREAT LAKES ORTHODONTICS, LTD.
D7750470060
HIBCC

1
041854332 *Terms of Use
No description.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Dental prosthesis restorative material, unfilled resin A material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.
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FDA Product Code

[?]
Product Code Product Code Name
EBI Resin, Denture, Relining, Repairing, Rebasing
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K112397 000
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Sterilization

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

[?]
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

6bbbcf2b-7f06-4356-ba0e-ade6808a4e8b
July 06, 2018
3
August 11, 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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
8008287626
info@greatlakesortho.com
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