DEVICE: Faci Forms (D798FFR0)

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Device Identifier (DI) Information

Faci Forms
FFR
FFR
RELIANCE ORTHODONTIC PRODUCTS INC
D798FFR0
HIBCC
1
Faci Forms are intended for use as a mold for creating temporary prosthetic composite teeth. These 5 medium and 5 large forms for the right side of the arch Size 22.
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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 veneer, custom-made A custom-made facial restoration of ceramic or polymer-based material (resin) used in aesthetic dentistry to correct the facial surface of a tooth. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
ECP Instrument, Ligature Tucking, Orthodontic
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in ambient conditions.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 08, 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

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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

[?]
6307734009
paulgropi@aol.com
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