FDA Registration
Active
🇺🇸 United States
ENGLE 310 PACKAGE WITH ENGLE 300 CHAIR WITH 310 DELIVERY
Reg #: 3020989
·
FEI: 3020989
·
Expires 2025
Products
1
Proprietary Names
15
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ENGLE DENTAL SYSTEMS, LLC
- Registration Number
- 3020989
- FEI Number
- 3020989
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 7205 NE Evergreen Pkwy Bldg E # 100
- City
- Hillsboro
- State
- OR
- ZIP
- 97124
- Country
- US
Regulatory Submissions
- 510(k) Number
- K983285
Owner / Operator
- Firm Name
- ENGLE DENTAL SYSTEMS, LLC
- Operator Number
- 10047558
- Address
- 7205 NE Evergreen PKWY, Bldg. B #100
- City
- Hillsboro
- State
- OR
- Postal Code
- 97124
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2014-10-06 |
Proprietary Names
ENGLE 310 PACKAGE WITH ENGLE 300 CHAIR WITH 310 DELIVERY
ENGLE 360 PACKAGE
ENGLE 310 PACKAGE
ENGLE 320 PACKAGE
ENGLE 2200 PACKAGE
ENGLE 320 PACKAGE WITH ENGLE 300 CHAIR WITH 320 DELIVERY
ENGLE 360 PACKAGE WITH ENGLE 300 CHAIR WITH 360 LEFT/RIGHT DELIVERY
ENGLE 1200 PACKAGE
ENGLE 1200 PACKAGE WITH ENGLE 310 CHAIR, AND 1200 OR 2200 DELIVERY SYSTEM
ENGLE WALL MOUNTED DELIVERY
ENGLE PANEL MOUNT DELIVERY
ENGLE HYGIENE PACKAGE
ENGLE DELIVERY CART
ENGLE REAR DELIVERY
ENGLE SIDE DELIVERY
Establishment Types
Manufacture Medical Device