Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| 25K IF-3 BEAVERTAIL INSERT | TM0004-872R | BONART CO., LTD. | ELC | 04719873120680 |
| 30K FS-SLIM PLASTIC INSERT/Darby | TM0004-972RT | BONART CO., LTD. | ELC | 04719873121373 |
| 30K SL-10S-L PLUS INSERT | TM0103-132R | BONART CO., LTD. | ELC | 04719873120949 |
| 30K SL-10S-R PLUS INSERT | TM0103-142R | BONART CO., LTD. | ELC | 04719873120956 |
| 25K P1000 INSERT | TM0103-272R | BONART CO., LTD. | ELC | 04719873120598 |
| MAGNET HANDPIECE WITH CABLE | MS0002-412RH | BONART CO., LTD. | ELC | 04719873121205 |
| 30K FS-10 PLASTIC INSERT | TM0004-772R | BONART CO., LTD. | ELC | 04719873120123 |
| 25K 120 ENDO INSERT | TU0201-012R | BONART CO., LTD. | ELC | 04719873120581 |
| Darby Dental Supply, LLC | 9530547 | DARBY DENTAL SUPPLY, LLC | ELC | 00889813021088 |
| 30K IF-5 BEAVERTAIL INSERT | TM0004-892R | BONART CO., LTD. | ELC | 04719873121021 |
| 30K P100 UNIVERSAL INSERT | TM0103-052R | BONART CO., LTD. | ELC | 04719873120109 |
| Darby Dental Supply, LLC | 9530549 | DARBY DENTAL SUPPLY, LLC | ELC | 00889813021101 |
| 30K FS-10 PLASTIC INSERT/Darby | TM0004-992RT | BONART CO., LTD. | ELC | 04719873121397 |
| M3II TRANSFORMER -115V | GP0006-291R | BONART CO., LTD. | ELC | 04719873120970 |
| 25K MAGNET HANDPIECE WITH CABLE | 73120697 | BONART CO., LTD. | ELC | 04719873120697 |
| 25K 90 ENDO INSERT | TU0201-002R | BONART CO., LTD. | ELC | 04719873120673 |
| ART TRIPLE BEND 30kHz | TM0005-072RT | BONART CO., LTD. | ELC | 04719873121540 |
| ULTRASONIC SCALER UNIT | ART-M3II | BONART CO., LTD. | ELC | 04719873120031 |
| 30K P10 UNIVERSAL INSERT | TM0007-062R | BONART CO., LTD. | ELC | 04719873120086 |
| 30K MAGNET HANDPIECE WITH CABLE | MO1004-052R | BONART CO., LTD. | ELC | 04719873120703 |
| 30K FS-SLIM PLASTIC INSERT | TM0004-792R | BONART CO., LTD. | ELC | 04719873120147 |
| Magnetostrictive Built-in Scaler (30K) | ART-MB3 | BONART CO., LTD. | ELC | 04719873121014 |