DEVICE: Perfect A Smile (D798PPB10)
Device Identifier (DI) Information
Perfect A Smile
PPB1
In Commercial Distribution
PPb1
RELIANCE ORTHODONTIC PRODUCTS INC
PPB1
In Commercial Distribution
PPb1
RELIANCE ORTHODONTIC PRODUCTS INC
Perfect A Smile Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners. This patented formula works with clear thermoforming aligner plastics. It is not recommended for use with cloudy (C) thermoforming materials.
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? |
---|---|---|---|---|
44728 | Dental shaded pontic kit |
A collection of devices intended to be used to produce artificial tooth veneers (shaded pontics) typically inside clear plastic custom-made teeth aligners (retainer-style orthodontic appliances). This is used to create the appearance of teeth inside the aligner to cover spaces where teeth may be missing for aesthetic purposes during treatment to realign teeth. The contents of the device may include polymer-based materials, dispenser gun, mixing tips, applicator brushes and practice aligner.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NXC | Aligner, Sequential |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K130237 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store at room temperature (15-30 degrees C) |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
731bac96-d7ee-43c1-8423-615cfe5425dd
July 06, 2018
3
August 06, 2016
July 06, 2018
3
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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