FDA UDI
In Commercial Distribution
🇺🇸 United States
Perfect A Smile
DI: D798PPD30
·
Model: PPD3
·
RELIANCE ORTHODONTIC PRODUCTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Perfect A Smile
- Primary DI
- D798PPD30
- Version / Model
- PPD3
- Catalog Number
- PPD3
- Company Name
- RELIANCE ORTHODONTIC PRODUCTS INC
- Labeler DUNS
- 113170088
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-10
- Public Version
- 1
- Public Version Date
- 2019-09-18
- Public Version Status
- New
- Public Device Record Key
- c5bea58e-d761-48c5-ace0-eece99c2c47e
Device Description
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. This is a 4g jar of the D3 Shade pontic paint.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NXC | Aligner, Sequential | Dental | 872.5470 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D798PPD30 | HIBCC |
Customer Contacts
- Phone
- 6307734009
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130237 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature (15-30 degrees C)