The following data is part of a premarket notification filed by Professional Dental Mfg., Inc. with the FDA for Pro-flex Disposable Prophy Angle.
| Device ID | K981869 |
| 510k Number | K981869 |
| Device Name: | PRO-FLEX DISPOSABLE PROPHY ANGLE |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | PROFESSIONAL DENTAL MFG., INC. 633 LAWRENCE ST. Batesville, AR 72501 |
| Contact | Bob Zahradnik |
| Correspondent | Bob Zahradnik PROFESSIONAL DENTAL MFG., INC. 633 LAWRENCE ST. Batesville, AR 72501 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-28 |
| Decision Date | 1998-08-11 |
| Summary: | summary |