FDA Registration
Active
🇺🇸 United States
Dental Engineering Laboratories, LLC
Reg #: 3013022399
·
FEI: 3013022399
·
Expires 2026
Products
6
Proprietary Names
13
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- Dental Engineering Laboratories, LLC
- Registration Number
- 3013022399
- FEI Number
- 3013022399
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 315 Bollay Drive, Suite 150
- City
- Goleta
- State
- CA
- ZIP
- 93117
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122501
Owner / Operator
- Firm Name
- Dental Engineering Laboratories
- Operator Number
- 10052682
- Address
- 315 Bollay Drive, Suite 150
- City
- Goleta
- State
- CA
- Postal Code
- 93117
- Country
- US
- Correspondent
- William D Ingalls
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bur, Dental | EJL | Class 1 | Dental | No | 2017-01-31 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2016-09-24 |
| Dental Implant Surgical Tray | OFY | Class 1 | Dental | No | 2018-09-21 |
| Endodontic Kit | NYD | Class 2 | Dental | No | 2017-12-08 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2017-03-14 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2017-03-14 |
Proprietary Names
TFRK-MT
GG-3M
TFRK-12
TFRK-S
TFRK-6
ZTip-E
ZTip-S
TFRK-CS
TFRK
TFRK-GPR
TFRK-L
TFRK-L+
TFRK-ME
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility