Manufacturer registered with FDA
Summit Dental Systems LLC.
Fort Lauderdale, FL, United States. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 20
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Summit Dental Systems LLC. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Viulux LED Light II | 2025 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | 1402 2 HP Delivery System1403 2 HP Rear Mounted Delivery System1407 3 HP Delivery System1408 3HP Rear Mounted Delivery System1607 Post Mounted Cuspidor1615D - Deluxe Assistant Arm1615E - Economy Assistant Arm1617 Swing Mounted Delivery System1660 Swing Mounted Cuspidor | 2025 |
| Dental Chair with Operative UnitKLC · Class 1 | Dental chairs & operative units | Maker | 1402 2HP Delivery System1403 2HP Rear Mounted Delivery System1407 3HP Delivery System1408 3HP Rear Mounted Delivery System6700M Marathon Chair6700M Marathon Chair and Accessories8700 DY Daytona Chair8700 DY Daytona Chair an Accessories | 2025 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | 6700M Marathon Chair8700 DY Daytona Chair | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Summit Dental Systems LLC. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Sds Dental, Inc. (3).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Oct 1986 | K863016 | DENTATUS L SET | Sds Dental, Inc. | KLC Dental Chair with Operative Unit |
| 1 Oct 1986 | K863021 | CM-II, CM-I WATER UNIT | Sds Dental, Inc. | EIA Operative Dental Unit |
| 29 Sep 1986 | K863019 | F-11 REFLECTOR / F-II STANDARD REFLECTOR | Sds Dental, Inc. | EAZ Dental Operating Light |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SUMMIT DENTAL SYSTEMS LLC.FDA reg. 3039246551 | Fort Lauderdale, FL, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10094631). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.