Identity
- Trade Name
- Smile Spa FDA UDI
- Generic Name
- Orthodontic appliance automated cleaner FDA UDI
- Device Name
- Ultrasonic UV cleaner; smile spa safely cleans: toothbrush heads, dentures, aligners, retainers, mouthguards, nightguards, TMJ appliances, water flosser tips, and more. FDA UDI
- Model / Reference
- 100-0367 FDA UDI
- Description
- Ultrasonic UV cleaner; smile spa safely cleans: toothbrush heads, dentures, aligners, retainers, mouthguards, nightguards, TMJ appliances, water flosser tips, and more. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850007728151 FDA UDI
- FDA Product Code
- FLG FDA UDI
- GMDN Term
- Orthodontic appliance automated cleaner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6150 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic appliance automated cleaner
Smile Spa by Access Dental Lab, LLC — Class I — 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
- MADA MEDICAL PRODUCTS, INC. — MADA MEDICAL PRODUCTS, INC. · Class II
- 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
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 |
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Manufacturer
- Manufacturer
- Access Dental Lab, LLC
Sources (1)
- FDA UDI eb6159a6-0439-496c-925e-1e73c5a7057f 34 fields · synced Jun 1, 2026