DEVICE: Ortho Veneer System (D798OVPA20)

Device Identifier (DI) Information

Ortho Veneer System
OVPA2
In Commercial Distribution
OVPA2
RELIANCE ORTHODONTIC PRODUCTS INC
D798OVPA20
HIBCC

1
113170088 *Terms of Use
Intended for use as a composite for the fabrication of veneers on undersized teeth. This is the 2.5 gm syringe of A2 Shade composite.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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
Custom-made dental composite resin kit A collection of customized equipment and supplies intended to be used to apply/polymerize composite resins to fill dental cavities or restore damaged dental tissue. It includes the composite resin, which may be self-, light-, or dual-cured, and additional devices which typically include a dental syringe, a mixing palette, a mixing pad, and brushes; it is customized for a specific patient. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
EBF Material, Tooth Shade, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K853001 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
Special Storage Condition, Specify: Store at room temperature (15-30 degrees C)
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

fa05ad15-8eb9-4894-88cb-fae0b503a2a8
July 06, 2018
3
August 06, 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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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