The following data is part of a premarket notification filed by Dentamerica with the FDA for Scalex 800.
| Device ID | K954820 |
| 510k Number | K954820 |
| Device Name: | SCALEX 800 |
| Classification | Scaler, Ultrasonic |
| Applicant | DENTAMERICA P.O. BOX 3200 Industry, CA 91744 |
| Contact | Jerry Huang |
| Correspondent | Jerry Huang DENTAMERICA P.O. BOX 3200 Industry, CA 91744 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-20 |
| Decision Date | 1996-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00304040005484 | K954820 | 000 |
| 00304040005477 | K954820 | 000 |
| 00858466005165 | K954820 | 000 |
| 00858466005158 | K954820 | 000 |
| 00858466005141 | K954820 | 000 |
| 00858466005134 | K954820 | 000 |
| 00858466005127 | K954820 | 000 |
| 00858466005110 | K954820 | 000 |
| 00858466005103 | K954820 | 000 |