Manufacturer registered with FDA
Cynosure LLC
Westford, MA, United States. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 6
- 510(k) clearances
- 0as applicant
- Markets registered in
- 14876 registrations outside the US
- Establishments
- 1United States
Registered in 14 markets
Where regulators' registries name Cynosure LLC as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Cynosure LLC | 6 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Cynosure LLC | 360 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | CYNOSURE, LLCCYNOSURE, INC. · CYNOSURE INC. | 320 | 1999–2022 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Cynosure, LLCCynosure Inc | 40 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CYNOSURE, INC.CYNOSURE, LLC · CYNOSURE, LLC. | 35 | 1995–2025 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Cynosure, IncCynosure, LLC · Cynosure, Inc. · +2 | 29 | 1999–2015 | Pure Global AI |
| Australia | TGA | Manufacturer | Cynosure LLC | 25 | 2007–2023 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Cynosure, Inc.Cynosure, LLC · Cynosure · +1 | 24 | 2007–2021 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Cynosure, IncCYNOSURE LLC. | 13 | — | Pure Global AI |
| China | NMPA | Registration holder | 美国赛诺秀公司Cynosure, LLC | 10 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CYNOSURE, LLCCYNOSURE INC | 9 | 2017–2022 | Pure Global AI |
| Israel | AMAR | Manufacturer | Cynosure INCCYNOSURE INC. · CynoSure Inc. · +1 | 7 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CYNOSURE, LLC.CYNOSURE, INC. | 3 | 2014–2019 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Cynosure LLC | 1 | 2025–2025 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Cynosure 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 |
|---|---|---|---|---|
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | Nubond Post, Screw | 2014 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | SELF SPAN CHEEK AND LIP RETRACTORS | 2016 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Roto-Pro, Non-Clogging Bur, Dental Bur | 2014 |
| Dental Electrosurgical Unit and AccessoriesEKZ · Class 2 | — | Maker | Dento-Surg 90 F.F.P. | 2014 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | POST KIT | 2014 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | NON-SLIP GRIP TIP PLIERS | 2016 |
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
Cynosure 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: Ellman Intl., Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Apr 1996 | K955176 | DENTO-SURGE | Ellman Intl., Inc. | EKZ Dental Electrosurgical Unit and Accessories |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CYNOSURE, LLCFDA reg. 1222993 | Westford, MA, United States | Complaint file establishment, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9006419). 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.