The following data is part of a premarket notification filed by Professional Dental Mfg., Inc. with the FDA for Proselect 3 Peridontal Therapy System.
| Device ID | K964596 |
| 510k Number | K964596 |
| Device Name: | PROSELECT 3 PERIDONTAL THERAPY SYSTEM |
| Classification | Scaler, Ultrasonic |
| Applicant | PROFESSIONAL DENTAL MFG., INC. P.O. BOX 4129 Batesville, AR 72503 |
| Contact | Bob Zahradnik |
| Correspondent | Bob Zahradnik PROFESSIONAL DENTAL MFG., INC. P.O. BOX 4129 Batesville, AR 72503 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-18 |
| Decision Date | 1997-04-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D813S423510 | K964596 | 000 |
| D8131007730 | K964596 | 000 |
| D81320540 | K964596 | 000 |
| D813S30500 | K964596 | 000 |
| D813S305500 | K964596 | 000 |
| D813S307010 | K964596 | 000 |
| D813S30921 | K964596 | 000 |
| D813S309300 | K964596 | 000 |
| D813S309400 | K964596 | 000 |
| D813S309500 | K964596 | 000 |
| D813S309601 | K964596 | 000 |
| D813S407500 | K964596 | 000 |
| D813S408010 | K964596 | 000 |
| D813S408510 | K964596 | 000 |
| D813S408710 | K964596 | 000 |
| D813S409010 | K964596 | 000 |
| D813S423500 | K964596 | 000 |
| D813S42350L0 | K964596 | 000 |
| D8131005400 | K964596 | 000 |