The following data is part of a premarket notification filed by Kavo America with the FDA for In Exam Intraoral Dental X-ray System.
| Device ID | K050019 |
| 510k Number | K050019 |
| Device Name: | IN EXAM INTRAORAL DENTAL X-RAY SYSTEM |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
| Contact | John R Miller |
| Correspondent | John R Miller KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-05 |
| Decision Date | 2005-01-31 |
| Summary: | summary |