Identity
- Trade Name
- Perfect A Smile FDA UDI
- Generic Name
- Dental shaded pontic kit FDA UDI
- Device Name
- 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 4g jar of dark shade pontic paint. FDA UDI
- Model / Reference
- PPA3 FDA UDI
- 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 4g jar of dark shade pontic paint. FDA UDI
Identifiers
- Catalog Number
- PPA3 FDA UDI
- Primary DI / UDI-DI
- D798PPA30 FDA UDI
- 510(k) Number
- K130237 FDA UDI
- FDA Product Code
- NXC FDA UDI
- GMDN Term
- Dental shaded pontic kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental shaded pontic kit
Perfect A Smile by Reliance Orthodontic Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental shaded pontic kit.
- Posterior Lower Pontic — Dentsply Sirona Orthodontics Inc. · Class II
- Lower Anterior Pontic — Dentsply Sirona Orthodontics Inc. · Class II
- Square Upper Pontic — Dentsply Sirona Orthodontics Inc. · Class II
- Paltop — Paltop Advanced Dental Solutions, Ltd. · Class II
- Essix® — Dentsply Sirona Orthodontics Inc. · Class II
- Posterior Lower Pontic — Dentsply Sirona Orthodontics Inc. · Class II
- Posterior Lower Pontic — Dentsply Sirona Orthodontics Inc. · Class II
- Lower Anterior Pontic — Dentsply Sirona Orthodontics Inc. · Class II
Cleared under the same submission
K130237 also covers:
- Perfect A Smile — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Perfect A Smile — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Perfect A Smile — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Perfect A Smile — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Perfect A Smile — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Perfect A Smile — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Perfect A Smile — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Perfect A Smile — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Perfect A Smile — RELIANCE ORTHODONTIC PRODUCTS, INC.
- Pontic Paint — RELIANCE ORTHODONTIC PRODUCTS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Reliance Orthodontic Products, Inc.
Sources (1)
- FDA UDI 9f9e3f4c-1168-4018-8d07-628996efe7fc 37 fields · synced May 30, 2026