Mectron
Piezoelectric ultrasonic handpiece with cord to be used in conjunction with Mectron Piezosurgery devices and tip inserts for the following applications: 1) Bone cutting, osteotomy,…
Piezoelectric ultrasonic handpiece with cord to be used in conjunction with Mectron Piezosurgery devices and tip inserts for the following applications: 1) Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures.including implantalogy, periodontal surgery, surgical orthodontic, and surgical endodonticprocedures; 2) Scaling applications, including: – Scaling: All general procedures for removal of supragingival and interdental calculus & plaquedeposits – Periodontology: Periodontal therapy and debridenient for all types of periodontal diseases,including periodontal pocket irrigation and cleaning: – Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-perchacondensation and retrograde preparation; – Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
14manufacturers in China registered for this device type
209catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), Guangxi (4), Shandong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| China Zhong YAN Chang Xing International Co., Ltd. | Zibo | Shandong | Contract manufacturer | 5 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Wenzhou Baiyu Glasses Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 10 |
| Shenzhen Ainengke Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 7 |
| Shenzhen Micro Electric Intelligence Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Changzhou Bomedent Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Nanning Baolai Medical Instrument Co., Ltd. | Nanning | Guangxi | Manufacturer | 4 |
Showing 12 of 14. All 14 manufacturers in China registered for Scaler, Ultrasonic
Record
| Listed by | Mectron SPA |
|---|---|
| FDA product code | ELC |
| Device type | Scaler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4850 |
| 510(k) | K151248 |
| Record published | 2016-08-30 |
| Record revised | 2019-02-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment temperature -10 to 70 °C; Handling environment atmospheric pressure 80 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Handling environment temperature 10 to 40 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IM2P | In distribution | |
| D3 | In distribution | |
| P11 | In distribution | |
| EL3 | In distribution | |
| OT10 -US | In distribution | |
| CROWN PREP TIP TA14D120 -US | In distribution | |
| PIEZOSURGERY ® TOUCH -essential -US- | In distribution | |
| OT7S-4 | In distribution | |
| S6 | In distribution | |
| IM1 -US | In distribution | |
| IM3.4P | In distribution | |
| D4 | In distribution | |
| OT5 -US | In distribution | |
| PIEZOSURGERY MT HANDPIECE | In distribution | |
| D2 | In distribution | |
| CROWN PREP TIP TA14D60 -US | In distribution | |
| SLIM SCALER HANDPIECE | In distribution | |
| S1-S | In distribution | |
| R5 | In distribution | |
| EN6R | In distribution | |
| PS TOUCH COMPLETE HANDPIECE | In distribution | |
| ER2 + K10 | In distribution | |
| PL0527 -US- | In distribution | |
| MULTIPIEZO -perio -US- | In distribution | |
| IM3P | In distribution | |
| D05120 + K10 -US | In distribution | |
| RD4 + K10 | In distribution | |
| TIP IC1 (5 PCS) -US- | In distribution | |
| OP6A -US | In distribution | |
| LED SCALER HANDPIECE | In distribution | |
| IM3A-15 | In distribution | |
| IM2P-15 | In distribution | |
| PIEZOSURGERY TOUCH | In distribution | |
| EN5R -US | In distribution | |
| EL1 | In distribution | |
| OT7 | In distribution | |
| S8 | In distribution | |
| OP5 -US | In distribution | |
| S6 + K10 | In distribution | |
| S4 + K10 | In distribution | |
| P16L + K10 | In distribution | |
| P3-4 -US | In distribution | |
| W1 -US- | In distribution | |
| PS2 | In distribution | |
| PR2 | In distribution | |
| P15 + K10 | In distribution | |
| R1 + K10 | In distribution | |
| W4-H | In distribution | |
| PP11 | In distribution | |
| S8 + K10 | In distribution | |
| PS6 | In distribution | |
| P10 + K10 | In distribution | |
| S7 + K10 | In distribution | |
| PIN IM1S | In distribution | |
| IP2-3 -US | In distribution | |
| EN2 | In distribution | |
| K10 | In distribution | |
| ER3 | In distribution | |
| OT2 | In distribution | |
| COMPACT-PIEZO P2K LED | In distribution | |
| E2 | In distribution | |
| OT14 -US | In distribution | |
| CROWN PREP TIP TA14D90 -US | In distribution | |
| R5 + K10 | In distribution | |
| ER1 + K10 | In distribution | |
| EX2 | In distribution | |
| S5 + K10 | In distribution | |
| IM4P | In distribution | |
| D1 + K10 | In distribution | |
| CROWN PREP TIP TA16D90 -US | In distribution | |
| COMPACT PIEZO LED -A- DBI | In distribution | |
| P3 | In distribution | |
| S7 | In distribution | |
| OP7 | In distribution | |
| IM1 AL -US | In distribution | |
| OT11 -US | In distribution | |
| OT9 -US | In distribution | |
| COMPACT PIEZO P2K – B – DBI | In distribution | |
| IM2.8A | In distribution | |
| OT6 | In distribution | |
| D3 + K10 | In distribution | |
| ER5 | In distribution | |
| S2 | In distribution | |
| PIEZOSURGERY WHITE | In distribution | |
| OP2 | In distribution | |
| CROWN PREP TIP TA16D120 -US | In distribution | |
| EXP4-R | In distribution | |
| PP12 | In distribution | |
| MDI 2.2 -US | In distribution | |
| S5 | In distribution | |
| S2 + K10 | In distribution | |
| OT13 -US | In distribution | |
| ER3 + K10 | In distribution | |
| OT5A -US | In distribution | |
| PL0419 -US- | In distribution | |
| S1 + K10 | In distribution | |
| OT1A -US | In distribution | |
| D2 + K10 | In distribution | |
| P2-3 SP -US | In distribution | |
| P14 + K10 | In distribution | |
| P2-3 -US | In distribution | |
| P2 | In distribution | |
| EX3 | In distribution | |
| R2 | In distribution | |
| EN3 -US | In distribution | |
| OT1 -US | In distribution | |
| P12 + K10 | In distribution | |
| IM1S -US | In distribution | |
| MULTIPIEZO PRO -perio -US- | In distribution | |
| PP10 | In distribution | |
| TIP D06007 (5 PCS) -US- | In distribution | |
| OP5A -US | In distribution | |
| MULTIPIEZO -easy -US- | In distribution | |
| P16R + K10 | In distribution | |
| P12 | In distribution | |
| IM2A-15 | In distribution | |
| OT4 -US | In distribution | |
| PS1 | In distribution | |
| S4 | In distribution | |
| IP3-4 -US | In distribution | |
| W2 | In distribution | |
| OT7A | In distribution | |
| OT8R | In distribution | |
| R1 | In distribution | |
| OP9 -US | In distribution | |
| P11 + K10 | In distribution | |
| P3 + K10 | In distribution | |
| K7 | In distribution | |
| PD0432A | In distribution | |
| R3 | In distribution | |
| IM3.4A | In distribution | |
| IM1 SP -US | In distribution | |
| P4 | In distribution | |
| W4 | In distribution | |
| EX1 | In distribution | |
| OT3 | In distribution | |
| PL0631 -US- | In distribution | |
| COMPACT-PIEZO P2K | In distribution | |
| SCALER HANDPIECE | In distribution | |
| EXP4-L | In distribution | |
| P13 | In distribution | |
| PR1 | In distribution | |
| OP8 -US | In distribution | |
| P1 | In distribution | |
| OP1 | In distribution | |
| ER1 | In distribution | |
| PIEZOSURGERY ® TOUCH -prof. Intl. -US- | In distribution | |
| R4 | In distribution | |
| E1 | In distribution | |
| R2 + K10 | In distribution | |
| P4 + K10 | In distribution | |
| EXP3-R | In distribution | |
| OP3 | In distribution | |
| ER4 + K10 | In distribution | |
| OT7S-3 | In distribution | |
| CROWN PREP TIP TA12D90 -US | In distribution | |
| R4 + K10 | In distribution | |
| MULTIPIEZO | In distribution | |
| PIEZOSURGERY GP | In distribution | |
| COMPACT PIEZO LED -B- DBI | In distribution | |
| EN5L-US | In distribution | |
| P13 + K10 | In distribution | |
| D07102 + K10 -US | In distribution | |
| RD3 + K10 | In distribution | |
| PL0719 -US- | In distribution | |
| IM4A | In distribution | |
| S1 | In distribution | |
| OP4 -US | In distribution | |
| ER2 | In distribution | |
| EXP3-L | In distribution | |
| IM3P-15 | In distribution | |
| EN1 -US | In distribution | |
| INSERT ICS -US | In distribution | |
| D1 | In distribution | |
| IM2.8P | In distribution | |
| TIP HOLDER DB1 | In distribution | |
| MDI 2.5 -US | In distribution | |
| MULTIPIEZO PRO | In distribution | |
| OT8L | In distribution | |
| ER4 | In distribution | |
| CROWN PREP TIP TA12D60 -US | In distribution | |
| RD5 + K10 | In distribution | |
| P14 | In distribution | |
| MULTIPIEZO PRO -basic -US- | In distribution | |
| P10 | In distribution | |
| MDI 1.9 -US | In distribution | |
| P2 + K10 | In distribution | |
| OT7-20 | In distribution | |
| EN6L | In distribution | |
| R3 + K10 | In distribution | |
| CROWN PREP TIP TA16D60 -US | In distribution | |
| S1-S + K10 | In distribution | |
| OT12S | In distribution | |
| K8 | In distribution | |
| W3 -US- | In distribution | |
| PP1 | In distribution | |
| IM3A | In distribution | |
| S3 + K10 | In distribution | |
| IM2A | In distribution | |
| P1 + K10 | In distribution | |
| EL2 | In distribution | |
| EN4 | In distribution | |
| S3 | In distribution | |
| COMPACT PIEZO P2K – A – DBI | In distribution | |
| K6 | In distribution | |
| D4 + K10 | In distribution | |
| OT5B -US | In distribution | |
| PIEZOSURGERY GP HANDPIECE | In distribution | |
| OT12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 501 |
| Piezon | E.M.S. Electro Medical Systems S.A. | 245 |
| Acteon | Satelec | 236 |
| Varios | Nakanishi Inc. | 158 |
| BioSonic | Coltene/Whaledent Gmbh & Co. KG | 142 |
| Cavitron® | Dentsply Professional | 137 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 113 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 83 |
| Obtura Spartan | Obtura Spartan Endodontics | 74 |
| Henry Schein | Henry Schein, Inc. | 48 |
| Baolai | Nanning Baolai Medical Instrument Co., Ltd. | 46 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 45 |
Showing 12 of 653. All products under Scaler, Ultrasonic
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.