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 a 4g jar of the Bleach Shade pontic paint. FDA UDI
- Model / Reference
- PPBL 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 a 4g jar of the Bleach Shade pontic paint. FDA UDI
Identifiers
- Catalog Number
- PPBL FDA UDI
- Primary DI / UDI-DI
- D798PPBL0 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 e0735fb1-01d8-4c21-a5de-4ba50a461987 37 fields · synced May 30, 2026