Identity
- Trade Name
- Cleaning Crystals, Packette FDA UDI
- Generic Name
- Orthodontic appliance cleanser FDA UDI
- Device Name
- Invisalign Cleaning Crystals FDA UDI
- Model / Reference
- 20127 FDA UDI
- Description
- Invisalign Cleaning Crystals FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063021407 FDA UDI
- FDA Product Code
- EFT FDA UDI
- GMDN Term
- Orthodontic appliance cleanser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3520 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic appliance cleanser
Cleaning Crystals, Packette by Align Technology, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic appliance cleanser.
- Retainer Brite® — Dentsply Sirona Orthodontics Inc. · Class I
- RETAINER BRITE® — Dentsply Sirona Orthodontics Inc. · Class I
- Retainer Brite® — Dentsply Sirona Orthodontics Inc. · Class I
- SmileSet Universal Cleaning Tablets - Sample 6pc — ORTHO DENTAL LAB, LLC · Class I
- RETAINER BRITE® — Dentsply Sirona Orthodontics Inc. · Class I
- RETAINER BRITE® — Dentsply Sirona Orthodontics Inc. · Class I
- RETAINER BRITE® — Dentsply Sirona Orthodontics Inc. · Class I
- Retainer Brite® — Dentsply Sirona Orthodontics Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Align Technology, Inc.
Sources (1)
- FDA UDI 6c92cc84-e288-4b28-b5af-ef7388e7d08c 33 fields · synced May 30, 2026