Registered with FDA
Summit Medical, LLC
Saint Paul, MN, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 12017–2017
- Markets registered in
- 13254 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 13 markets
Where regulators' registries name Summit Medical, 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 | Lister | Summit Medical, LLC | 1 clearances | 2017–2017 | Below |
| Canada | Health Canada | Registration holder | SUMMIT MEDICAL, LLCSUMMIT MEDICAL LTD. | 92 | 2000–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Summit Medical, LLCSummit Medical Ltd | 66 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Summit Medical LLCSummit Medical Ltd | 22 | 2010–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Summit Medical LtdSummit Medical LLC | 21 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Summit Medical, LLCSummit Medical, Inc · Summit Medical Inc. · +2 | 15 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Summit Medical LtdSummit Medical · SUMMIT MEDICAL LIMITED · +2 | 11 | 1999–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Summit Medical Ltd | 10 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SUMMIT MEDICAL INC. | 5 | 2013–2013 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SUMMIT MEDICAL INCSUMMIT MEDICAL INC. · SUMMIT MEDICAL, INC. | 4 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Summit Medical, LLCSummit Medical Ltd | 4 | 2022–2024 | Pure Global AI |
| China | NMPA | Registration holder | 美国顶峰医疗有限责任公司 Summit Medical, LLC萨米特医疗有限公司Summit Medical Limited | 2 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Summit Medical LimitedSummit Medical, LLC | 2 | 2025–2026 | 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 Summit Medical, 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 |
|---|---|---|---|---|
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Lister | Dental Syringe | 2023 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Lister | Oral Rotating Biopsy Punch | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Summit Medical, LLC as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Apr 2017 | K162046 | MINNE TIES MMF Suture System | DYX Intraoral Wire Lock and Ligature |
Some of these clearances are listed with FDA today by another company: Invisian Medical LLC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SUMMIT MEDICAL LLCFDA reg. 3008719017 | Saint Paul, MN, United States | Complaint file establishment |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033920). 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.