DEVICE: Ortho Veneer System (D798OVPA20)
Device Identifier (DI) Information
Ortho Veneer System
OVPA2
In Commercial Distribution
OVPA2
RELIANCE ORTHODONTIC PRODUCTS INC
OVPA2
In Commercial Distribution
OVPA2
RELIANCE ORTHODONTIC PRODUCTS INC
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
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47906 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EBF | Material, Tooth Shade, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store at room temperature (15-30 degrees C) |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fa05ad15-8eb9-4894-88cb-fae0b503a2a8
October 29, 2018
4
August 06, 2016
October 29, 2018
4
August 06, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
6307734009
paulgropi@aol.com
paulgropi@aol.com