The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Spirit S1/s2.
| Device ID | K962071 |
| 510k Number | K962071 |
| Device Name: | SPIRIT S1/S2 |
| Classification | Unit, Operative Dental |
| Applicant | PELTON & CRANE CO. 11727 FRUEHAUF DR. Charlotte, NC 28243 |
| Contact | Kristi Kunkel |
| Correspondent | Kristi Kunkel PELTON & CRANE CO. 11727 FRUEHAUF DR. Charlotte, NC 28243 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-28 |
| Decision Date | 1996-08-06 |