Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| 25K P100 UNIVERSAL INSERT | TM0103-032R | BONART CO., LTD. | ELC | 04719873120093 |
| 25K FS-SLIM PLASTIC INSERT/Darby | TM0004-962RT | BONART CO., LTD. | ELC | 04719873121366 |
| M1 TRANSFORMER-110V | GP0005-731R | BONART CO., LTD. | ELC | 04719873120741 |
| 25K P100(R) UNIVERSAL INSERT | TM0103-122R | BONART CO., LTD. | ELC | 04719873120772 |
| 25K FS-10 PLASTIC INSERT/Darby | TM0004-982RT | BONART CO., LTD. | ELC | 04719873121380 |
| ULTRASONIC SCALER UNIT | ART-M1 | BONART CO., LTD. | ELC | 04719873120024 |
| 25K FS-10 PLASTIC INSERT | TM0004-762R | BONART CO., LTD. | ELC | 04719873120116 |
| Darby Dental Supply, LLC | 9530546 | DARBY DENTAL SUPPLY, LLC | ELC | 00889813021071 |
| 25K P10 UNIVERSAL INSERT | TM0006-162R | BONART CO., LTD. | ELC | 04719873120079 |
| 25K FS-SLIM PLASTIC INSERT | TM0004-782R | BONART CO., LTD. | ELC | 04719873120130 |
| FOOT PEDAL | PP0031-002R | BONART CO., LTD. | ELC | 04719873120154 |
| Darby Dental Supply, LLC | 9530548 | DARBY DENTAL SUPPLY, LLC | ELC | 00889813021095 |
| Magnetostrictive Built-in Scaler (25K) | ART-MB3 | BONART CO., LTD. | ELC | 04719873120871 |
| ART TRIPLE BEND 25kHz | TM0005-062RT | BONART CO., LTD. | ELC | 04719873121533 |
| 25K P100(L) UNIVERSAL INSERT | TM0103-112R | BONART CO., LTD. | ELC | 04719873120765 |