The following data is part of a premarket notification filed by A-dec, Inc. with the FDA for A-dec/w&h Synea Sonic Scaler Handpiece, Models Za-55, Za-55 L, Za-55 Lm, Za-55m, Sf1lm.
| Device ID | K100647 |
| 510k Number | K100647 |
| Device Name: | A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM |
| Classification | Scaler, Ultrasonic |
| Applicant | A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Contact | Thomas H Louisell |
| Correspondent | Thomas H Louisell A-DEC, INC. 2601 CRESTVIEW DR. Newberg, OR 97132 -9257 |
| Product Code | ELC |
| CFR Regulation Number | 872.4850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-08 |
| Decision Date | 2010-07-09 |