Registered with FDA
Ransom & Randolph. LLC.
Maumee, OH, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 51977–1978
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1976–2026
Registered in 2 markets
Where regulators' registries name Ransom & Randolph. 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 | Ransom & Randolph. LLC. | 5 clearances | 1977–1978 | Below |
| South Korea | MFDS | Manufacturer | Ransom & Randolphransom&Randolph | 3 | 1999–2012 | 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 Ransom & Randolph. 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 |
|---|---|---|---|---|
| Base Metal AlloyEJH · Class 2 | Dental alloys | Lister | Neoloy Plus | 2022 |
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 Ransom & Randolph. LLC. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 10 Oct 1978 | K781605 | R&R ABSORBENT POINTS | EKN Endodontic Paper Point |
| 16 Feb 1978 | K780199 | PROPHY ANGLES, R&R | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 16 Feb 1978 | K780198 | PROPHY CUPS, R&R | EHK Prophylaxis Cup |
| 3 Aug 1977 | K771347 | R&R ALSTON CARBIDE BURS | EJL Dental Bur |
| 5 Apr 1977 | K770598 | ENDODONTIC INSTRUMENTS, R&R CUTWELL | EKP Endodontic Pulp Canal Reamer |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| RANSOM & RANDOLPH. LLC.FDA reg. 3001157343 | Maumee, OH, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10084137). 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.