The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Acucam Concept Iv Fwt, Model 110-0185g1.
| Device ID | K032904 |
| 510k Number | K032904 |
| Device Name: | ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 |
| Classification | Unit, Operative Dental |
| Applicant | DENTSPLY INTL. 901 W. OAKTON ST. Des Plaines, IL 60018 |
| Contact | John R Miller |
| Correspondent | John R Miller DENTSPLY INTL. 901 W. OAKTON ST. Des Plaines, IL 60018 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-17 |
| Decision Date | 2003-10-14 |
| Summary: | summary |