Spirit II and Spirit Treatment Center

• • Terminated Z-1177-2012 FDA Not yet classified ·initiated 20 Feb 2012

  Modification of the Pelton & Crane Spirit 3000 unit disabled the TLC SAFEdrive feature rendering it ineffective in detecting whether the handpiece is potentially damaged or heating up.

510(k) Number

K946187 ↗

FDA Product Code

EIA

Device Class

Class I

Regulation

21 CFR Part 872.6640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Siemens Sirona(R) Dental Chair

  Class I

  FDA 510(k) K863484 Active Cleared 19 Sep 1986

• Orthophos Plus and Orthophos Plus/CD

  Class II

  FDA 510(k) K972249 Active Cleared 12 Sep 1997

• Heliodent Ds

  Class II

  FDA 510(k) K960819 Active Cleared 29 Mar 1996

• Resubmitted Water Purifier for Use W/Dental Treat

  Class I

  FDA 510(k) K901672 Active Cleared 6 Jul 1990

• Sirolux Fantastic

  Class I

  FDA 510(k) K935390 Active Cleared 10 Dec 1993

• Heliodent Md

  Class II

  FDA 510(k) K950030 Active Cleared 3 Feb 1995

See all devices from Pelton & Crane Co. →