Identity
- Trade Name
- MADA MEDICAL PRODUCTS, INC. FDA UDI
- Generic Name
- Orthodontic appliance automated cleaner FDA UDI
- Device Name
- An electromechanical device designed to clean soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. The orthodontic appliances are typically placed in a receptacle and water together with an appropriate cleansing tablet or solution, and cleaned through an automated cycle. An audible signal may alert the user that the program has finished. FDA UDI
- Model / Reference
- 6008 FDA UDI
- Description
- An electromechanical device designed to clean soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. The orthodontic appliances are typically placed in a receptacle and water together with an appropriate cleansing tablet or solution, and cleaned through an automated cycle. An audible signal may alert the user that the program has finished. FDA UDI
Identifiers
- Catalog Number
- 6008 FDA UDI
- Primary DI / UDI-DI
- 00815160021112 FDA UDI
- FDA Product Code
- MEC FDA UDI
- GMDN Term
- Orthodontic appliance automated cleaner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6992 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
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 automated cleaner
Mada Medical Products, Inc. by Mada Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic appliance automated cleaner.
- Cordless Sonic Cleaner — Dentsply Sirona Orthodontics Inc. · Class I
- Invisalign™ Ultrasonic Cleaning Station — Align Technology, Inc. · Class I
- SmileSet Rechargeable Ultrasonic Cleaner - Black — ORTHO DENTAL LAB, LLC · Class I
- SmileSet QX105 Ultrasonic Cleaner - Mint — ORTHO DENTAL LAB, LLC · Class I
- SmileSet QX105 Ultrasonic Cleaner - Black — ORTHO DENTAL LAB, LLC · Class I
- RETAINER BRITE® — Dentsply Sirona Orthodontics Inc. · Class I
- Cordless Sonic Cleaner — Dentsply Sirona Orthodontics Inc. · Class I
- Smile Spa — Access Dental Lab, LLC · 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 II | Pending data |
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Manufacturer
- Manufacturer
- Mada Medical Products, Inc.
Sources (1)
- FDA UDI 5cac81c9-7517-488c-9a6f-62c365275f52 35 fields · synced May 30, 2026