The following data is part of a premarket notification filed by Agfa Corp. with the FDA for Adc Dental.
| Device ID | K021542 |
| 510k Number | K021542 |
| Device Name: | ADC DENTAL |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29602 -9048 |
| Contact | Jeff Jedlicka |
| Correspondent | Jeff Jedlicka AGFA CORP. 10 SOUTH ACADEMY ST. Greenville, SC 29602 -9048 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-10 |
| Decision Date | 2002-08-06 |
| Summary: | summary |