Company ยท US
Pelton & Crane Co.
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2018. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
9recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 26, 2018 | K171872 | P50 Series Dental Operative Unit and Accessories Pelton & Crane | EIA |
| Sep 18, 2015 | K143696 | Spirit Pelton & Crane | EIA |
| Sep 12, 1997 | K972249 | ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD Pelton & Crane Co. | EHD |
| Sep 5, 1997 | K972168 | SIDEXIS DIGITAL RADIOGRAPHY SYSTEM Pelton & Crane Co. | EHD |
| Feb 28, 1997 | K945117 | DELTA Pelton & Crane Co. | FLE |
| Aug 6, 1996 | K962071 | SPIRIT S1/S2 Pelton & Crane Co. | EIA |
| Mar 29, 1996 | K960819 | HELIODENT DS Pelton & Crane Co. | EAP |
| May 23, 1995 | K950299 | CEREC 2 Pelton & Crane Co. | ELW |
| Mar 1, 1995 | K946187 | SPIRIT II AND SPIRIT TREATMENT CENTER Pelton & Crane Co. | EIA |
| Feb 3, 1995 | K950030 | HELIODENT MD Pelton & Crane Co. | EAP |
| Jul 29, 1994 | K936068 | ORTHOPHOS 3/ ORTHOPHOS 3C Pelton & Crane Co. | EAP |
| Dec 10, 1993 | K935390 | SIROLUX FANTASTIC Pelton & Crane Co. | EAZ |
| Jul 6, 1990 | K901672 | RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT Pelton & Crane Co. | EIA |
| Sep 19, 1986 | K863484 | SIEMENS SIRONA(R) DENTAL CHAIR Pelton & Crane Co. | KLC |
| May 6, 1983 | K837382 | OPTISON ULTRASONIC SCALER Pelton & Crane Co. | |
| Aug 23, 1976 | K760404 | BI-CENTRIC SYSTEM Pelton & Crane Co. | KLC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2012 | Pelton & Crane Company Pelton & Crane Spirit 3000 dental operative unit with the TLC SAFEdrive option, 1727 Fuehauf Dr. Charlotte, NC 28273
Product Usage:
The intended use of the dental operative unit is for supplying pow Terminated |
EIA | K946187 |
| Mar 30, 2011 | Pelton & Crane Company Pelton & Crane Spirit 1800 dental chair (Model #SP18) Terminated |
NRU | None listed |
| Mar 30, 2011 | Pelton & Crane Company Pelton & Crane Spirit 3000 dental chair (Model #SP30) Terminated |
NRU | None listed |
| Apr 9, 2010 | Pelton & Crane Company Pelton & Crane Spirit 3000 Dental Chair.
The intended use of this device is for properly positioning patients to perform dental procedures. Terminated |
KLC | None listed |
| Apr 1, 2010 | Pelton & Crane Company Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.
Intended for the properly positioning of patients to perform dental procedures. Terminated |
KLC | K760404 |
| Apr 1, 2010 | Pelton & Crane Company Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.
Intended for the properly positioning of patients to perform dental procedures. Terminated |
KLC | K760404 |
| Apr 1, 2010 | Pelton & Crane Company Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.
Intended for the properly positioning of patients to perform dental procedures. Terminated |
KLC | K760404 |
| Apr 1, 2010 | Pelton & Crane Company Pelton & Crane Dental Chairs, Spirit 1500 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.
Intended for the properly positioning of patients to perform dental procedures. Terminated |
KLC | K760404 |
| Apr 1, 2010 | Pelton & Crane Company Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28273.
Intended for the properly positioning of patients to perform dental procedures. Terminated |
KLC | K760404 |