The following data is part of a premarket notification filed by Safco Dental Supply with the FDA for Prophy Champ Cordless Electronic Handpiece.
| Device ID | K870797 |
| 510k Number | K870797 |
| Device Name: | PROPHY CHAMP CORDLESS ELECTRONIC HANDPIECE |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | SAFCO DENTAL SUPPLY 624 W. ADAMS ST. Chicago, IL 60606 |
| Contact | Harold Saffir |
| Correspondent | Harold Saffir SAFCO DENTAL SUPPLY 624 W. ADAMS ST. Chicago, IL 60606 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-27 |
| Decision Date | 1987-05-01 |