# K946187: Spirit II and Spirit Treatment Center

- Pathway: 510(k) (Traditional)
- Applicant: Pelton & Crane Co.
- Decided: Mar 1, 1995 after 71 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Feb 20, 2012 · Not classified · Z-1177-2012: 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.

Source page: https://510kreport.com/device/K946187
Methodology: https://510kreport.com/methodology