FDA Registration
Active
🇺🇸 United States
EVOLVE DENTAL TECHNOLOGIES, INC.
Reg #: 3010407924
·
FEI: 3010407924
·
Expires 2026
Products
7
Proprietary Names
9
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- EVOLVE DENTAL TECHNOLOGIES, INC.
- Registration Number
- 3010407924
- FEI Number
- 3010407924
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5 Vanderbilt
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K983477
Owner / Operator
- Firm Name
- Evolve Dental Technologies, Inc.
- Operator Number
- 10044828
- Address
- 5 Vanderbilt
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
- Correspondent
- Crystal Lopez
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2013-08-02 |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | Class 1 | General Hospital | No | 2013-08-02 |
| Liner, Cavity, Calcium Hydroxide | EJK | Class 2 | Dental | No | 2016-09-06 |
| Material, Impression | ELW | Class 2 | Dental | No | 2017-03-09 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2013-08-02 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2013-08-02 |
| Accessories, Retractor, Dental | EIF | Class 1 | Dental | No | 2025-04-14 |
Proprietary Names
KöR Disposable Impression Trays
KöR EVA Sheets
KöR Teeth Desensitizer Swabs
KoR Putty Regular Set
KoR Putty Fast Set
KöR Oral Suction Tip
KoR Light Body Wash
KöR Dam
KoR Cheek Retractor
Establishment Types
Repack or Relabel Medical Device