The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Heliodent Md.
| Device ID | K950030 |
| 510k Number | K950030 |
| Device Name: | HELIODENT MD |
| Classification | Unit, X-ray, Intraoral |
| Applicant | PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
| Contact | Kristi Kunkel |
| Correspondent | Kristi Kunkel PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800 |
| Product Code | EAP |
| CFR Regulation Number | 872.1810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-04 |
| Decision Date | 1995-02-03 |