Mectron
MT-Bone is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: - Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral…
MT-Bone is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: – Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures; – Scaling applications, including: Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; o Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; o Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation; o Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Mectron SPA |
|---|---|
| FDA product code | DZI |
| Device type | Drill, Bone, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| 510(k) | K242432 |
| Record published | 2024-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature -10 to 60 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity -10 to 60 % RH; Storage environment temperature -10 to 60 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MT-Bone -US- | In distribution | |
| PD0535A -US- | In distribution | |
| PD0223A -US- | In distribution | |
| PD0118A -US- | In distribution | |
| SLO-H | In distribution | |
| PL2 | In distribution | |
| EX0610 | In distribution | |
| PD0118B | In distribution | |
| PD0620A -US- | In distribution | |
| PD0328A -US- | In distribution | |
| EX0410 | In distribution | |
| TIP TF16D90 -US- | In distribution | |
| TIP TF12D60 -US- | In distribution | |
| PIEZODRILL MT HANDPIECE | In distribution | |
| MF1004L | In distribution | |
| SLC | In distribution | |
| PiEZOSURGERY HANDPIECE -US | In distribution | |
| PD0535B | In distribution | |
| PD0328B -US- | In distribution | |
| OP1125 | In distribution | |
| K11 | In distribution | |
| PD0223B | In distribution | |
| OP1225 | In distribution | |
| PL3 | In distribution | |
| PD0118A | In distribution | |
| PD0432A -US- | In distribution | |
| MANIPOLO PIEZOSURGERY® medical + | In distribution | |
| OP6 -US | In distribution | |
| TIP TF12D90 -US- | In distribution | |
| EX0510 | In distribution | |
| SLE1 | In distribution | |
| MT-Bone | In distribution | |
| PD0535B -US- | In distribution | |
| MT1817L | In distribution | |
| SLE2 | In distribution | |
| PD0432B | In distribution | |
| PD0328A | In distribution | |
| PD0620B -US- | In distribution | |
| PD0223B -US- | In distribution | |
| OP3A | In distribution | |
| PD0535A | In distribution | |
| PD0328B | In distribution | |
| PL1 | In distribution | |
| PD0432B -US- | In distribution | |
| SLS | In distribution | |
| TIP TF16D60 -US- | In distribution | |
| PD0118B -US- | In distribution | |
| PD0223A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drill, Bone, Powered | Synthes Gmbh | 150 |
| Acteon | Satelec | 87 |
| Neoss Implant System | Neoss AB | 74 |
| OneDrill Surgical Drill | Osseofuse International Inc. | 48 |
| Silfradent srl | Silfradent SRL | 45 |
| MatrixMANDIBLE | Synthes Gmbh | 31 |
| DIRECTguide™ Step Drill | Implant Direct Sybron Manufacturing LLC | 31 |
| DIRECTguide™ Guided Step Drill | Implant Direct Sybron Manufacturing LLC | 30 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 28 |
| VarioSurg | Nakanishi Inc. | 22 |
| Nobel Biocare® | Nobel Biocare AB | 20 |
| Drill, Bone, Powered | Synthes (U.S.A.) LP | 19 |
Showing 12 of 265. All products under Drill, Bone, Powered
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.