DEVICE: Faci Forms (D798FFR0)

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Device Record History
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Device Identifier (DI) Information
Faci Forms
FFR
In Commercial Distribution
FFR
RELIANCE ORTHODONTIC PRODUCTS INC
D798FFR0
HIBCC

1
113170088 *Terms of Use
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© 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?
38645 Dental veneer, professional
A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ECP Instrument, Ligature Tucking, Orthodontic
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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: Store in ambient conditions.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
078026f0-0aa3-4db0-8dae-8a2a2d82c489
February 05, 2021
3
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

[?]
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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