FDA Registration
Active
🇺🇸 United States
1616D Assistant Arm
Reg #: 3037000005
·
FEI: 3037000005
·
Expires 2025
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MD COMPONENTS INC. DBA SUMMIT DENTAL SYSTEMS
- Registration Number
- 3037000005
- FEI Number
- 3037000005
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6500 Nw 12th Ave Ste 110
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33309
- Country
- US
Regulatory Submissions
- 510(k) Number
- K863021
Owner / Operator
- Firm Name
- MD Components Inc. DBA Summit Dental Systems
- Operator Number
- 10092976
- Address
- 6500 NW 12th Avenue, Suite 110
- City
- Fort Lauderdale
- State
- FL
- Postal Code
- 33309
- Country
- US
- Correspondent
- Cesar Coral
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Operative Dental | EIA | Class 1 | Dental | No | 2025-03-12 |
Proprietary Names
1616D Assistant Arm
SDS Delivery Systems:1403
1615D Assistant Arm
SDS Delivery Systems:1402
1617 Rear Mounted Assistant Arm
SDS Delivery Systems:1407
Cuspidor 1660
1616E Assistant Arm
1615E Assistant Arm
Cuspidors: 1607
Establishment Types
Manufacture Medical Device