Data / Medical devices / United States / Summit Dental Systems LLC.
Summit Dental Systems LLC.: FDA-registered device maker in Fort Lauderdale, FL, United States, 3 510(k) clearances
Summit Dental Systems LLC. is registered with the FDA (registration 3039246551) in Fort Lauderdale, FL, United States. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 1, 1986. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3039246551
- Address
- 6500 Nw 12th Ave Ste 110, Fort Lauderdale, FL, United States, 33309
- Owner or operator
- Summit Dental Systems LLC. (10094631)
- Roles
- Manufacturer
- First device listed
- December 11, 2025
- Registered through
- 2026
- Brand names listed
- 1402 2 HP Delivery System, 1402 2HP Delivery System, 1403 2 HP Rear Mounted Delivery System, 1403 2HP Rear Mounted Delivery System, 1407 3 HP Delivery System, 1407 3HP Delivery System, 1408 3HP Rear Mounted Delivery System, 1607 Post Mounted Cuspidor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chair, Dental, With Operative Unit | KLC | 1 | Manufacturer | accessdata.fda.gov |
| Chair, Dental, Without Operative Unit | NRU | 1 | Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Manufacturer | accessdata.fda.gov |
| Stool, Operating-Room | FZM | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 1, 1986 | K863021 | CM-II, CM-I WATER UNIT | EIA | Substantially Equivalent | Sds Dental, Inc. | accessdata.fda.gov |
| October 1, 1986 | K863016 | DENTATUS L SET | KLC | Substantially Equivalent | Sds Dental, Inc. | accessdata.fda.gov |
| September 29, 1986 | K863019 | F-11 REFLECTOR / F-II STANDARD REFLECTOR | EAZ | Substantially Equivalent | Sds Dental, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Stool, Operating-Room
- All makers of Chair, Dental, Without Operative Unit
- All makers of Light, Operating, Dental
- All makers of Chair, Dental, With Operative Unit
- All makers of Unit, Operative Dental
Updated October 1, 1986. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.