FDA Registration
Active
🇺🇸 United States
GURUNANDA LLC
Reg #: 3014468707
·
FEI: 3014468707
·
Expires 2026
Products
15
Proprietary Names
14
Establishment Types
4
Classifications
15
Registration Details
- Registration Name
- GURUNANDA LLC
- Registration Number
- 3014468707
- FEI Number
- 3014468707
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6645 CABALLERO BLVD.
- City
- Buena Park
- State
- CA
- ZIP
- 90620
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180207
Owner / Operator
- Firm Name
- GURUNANDA LLC
- Operator Number
- 10061329
- Address
- 6645 CABALLERO BLVD.
- City
- Buena Park
- State
- CA
- Postal Code
- 90620
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-06-01 |
| Scraper, Tongue | LCN | Class 1 | Dental | No | 2019-12-13 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2024-03-07 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2022-04-14 |
| Eraser, Dental Stain | MAU | Class 1 | Dental | No | 2021-06-06 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2020-07-03 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2025-08-27 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2022-12-29 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-09-16 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2019-10-11 |
| Saliva, Artificial | LFD | Class U | Unknown | No | 2026-01-12 |
| Floss, Dental | JES | Class 1 | Dental | No | 2019-10-11 |
| Pick, Massaging | JET | Class 1 | Dental | No | 2024-12-12 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2021-06-06 |
| Cleanser, Denture, Over The Counter | EFT | Class 1 | Dental | No | 2025-07-28 |
Proprietary Names
Non-contact Infrared Forehead Thermometer
GURUNANDA
TruMed Digital Thermometer
MENTADENT WHITENING
COMFORTFLOW BOTTLE
NETI POT
GuruNanda Retainer & Denture Cleaning Pod
Gurunanda Disposable Face Mask
DENTALGURU KIDS PIXEL
GuruNanda Dry Mouth Oral Rinse
GuruNanda Dry Mouth Spray
DENTAL GURU CHARCOAL FLEXI PICKS
MENTADENT DAZZLE BRIGHT
GuruNanda Aligner and Retainer Cleaning Foam
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)