Not currently registered with FDA under this name
Pelton & Crane
Charlotte, NC, United States. Named as applicant on 14 dental 510(k) clearances between 1976 and 2018. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 141976–2018
- Markets registered in
- 47 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1976–2026
Registered in 4 markets
Where regulators' registries name Pelton & Crane as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Pelton & Crane | 14 clearances | 1976–2018 | Below |
| Taiwan | TFDA | Manufacturer | PELTON & CRANE | 5 | 2005–2013 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | PELTON & CRANE | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | PELTON & CRANE COMPANY | 1 | 1999–1999 | 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
510(k) clearances
Clearances on which FDA names Pelton & Crane as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 26 Apr 2018 | K171872 | P50 Series Dental Operative Unit and Accessories | EIA Operative Dental Unit |
| 18 Sep 2015 | K143696 | Spirit | EIA Operative Dental Unit |
| 12 Sep 1997 | K972249 | ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD | EHD Extraoral with Timer X-Ray Unit |
| 5 Sep 1997 | K972168 | SIDEXIS DIGITAL RADIOGRAPHY SYSTEM | EHD Extraoral with Timer X-Ray Unit |
| 6 Aug 1996 | K962071 | SPIRIT S1/S2 | EIA Operative Dental Unit |
| 29 Mar 1996 | K960819 | HELIODENT DS | EAP Intraoral X-Ray Unit |
| 23 May 1995 | K950299 | CEREC 2 | ELW Impression Material |
| 1 Mar 1995 | K946187 | SPIRIT II AND SPIRIT TREATMENT CENTER | EIA Operative Dental Unit |
| 3 Feb 1995 | K950030 | HELIODENT MD | EAP Intraoral X-Ray Unit |
| 29 Jul 1994 | K936068 | ORTHOPHOS 3/ ORTHOPHOS 3C | EAP Intraoral X-Ray Unit |
| 10 Dec 1993 | K935390 | SIROLUX FANTASTIC | EAZ Dental Operating Light |
| 6 Jul 1990 | K901672 | RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT | EIA Operative Dental Unit |
| 19 Sep 1986 | K863484 | SIEMENS SIRONA(R) DENTAL CHAIR | KLC Dental Chair with Operative Unit |
| 23 Aug 1976 | K760404 | BI-CENTRIC SYSTEM | KLC Dental Chair with Operative Unit |
Sources
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 of the most recent filing, which can be a US agent.