Acteon
This medical device is intended for prophylaxis—scaling, periodontics, endodontics, and for preservation and restoration dentistry, including prosthesis. The electrical signal emitted by…
This medical device is intended for prophylaxis → scaling, periodontics, endodontics, and for preservation and restoration dentistry, including prosthesis. The electrical signal emitted by the medical device is supplied to the dental ultrasonic handpiece. This is connected to the medical device via a cord. The handpiece is comprised of a piezoelectric ceramic transducer, which transforms the electrical signal into ultrasonic vibrations. Mechanical vibrations are then transmitted to the tip or dental file attached to the end of the ultrasonic handpiece.
14manufacturers in China registered for this device type
236catalogue numbers in this listing
6510(k) clearances naming this product code
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 | Satelec, United States |
|---|---|
| FDA product code | ELC |
| Device type | Scaler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4850 |
| 510(k) | K113430 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PAM MINILED AO BLUE RAY 3 | In distribution | |
| NEWTRON P5 XS BLED NO TIP CBVS | In distribution | |
| PRO-ULTRA NEWTRON HANDPIECE | In distribution | |
| BOX 4 FILES K10 LG21 MORITA | In distribution | |
| HANDPIECE NEWTRON SLIM B.LED 54.0581.00 | In distribution | |
| KIT BDR GII SS PAM | In distribution | |
| P5 NEWTRON CSA | In distribution | |
| NEWT LED OEM KIT AG61 +HARNESS | In distribution | |
| NEWT BOOSTER HPNEWT CBVS KITV4 | In distribution | |
| DUAL HANDPIECE ULTRASONIC KIT | In distribution | |
| HANDPIECE P5 PRO VET | In distribution | |
| MOD OEM MINILED NU 24V +/-20% | In distribution | |
| P5 NEWTRON LED | In distribution | |
| NEWTRON BOOSTER USA NO TIP | In distribution | |
| SP NEWTRON LED MIDMARK | In distribution | |
| TIP EX3 | In distribution | |
| TIP H2L | In distribution | |
| KIT IMPLANTPROTECT | In distribution | |
| TIP SO4 | In distribution | |
| HANDPIECE NEWTRON SLIM 54.0580.00 | In distribution | |
| HANDPIECE NEWTRON SLIM B.LED BL BT | In distribution | |
| P5 XS LED 115V NO TIPS | In distribution | |
| SP NEWT LED 4K3,7V V3 ADEC CTL | In distribution | |
| SP NEWTRON LED 4K3,7V US CTRL | In distribution | |
| BOX 4 TIPS PH2L | In distribution | |
| TIP 10Z MORITA | In distribution | |
| TIP ASLD | In distribution | |
| ULTRAWAVE P5 | In distribution | |
| TIP ET40 | In distribution | |
| TIP 1 | In distribution | |
| P5 NEWTRON 115V | In distribution | |
| TIP PMS3 | In distribution | |
| SP NEWT. USA CD F00184/1-2-10P | In distribution | |
| TIP PFU | In distribution | |
| SP NEWTRON LED CORD ADEC MG | In distribution | |
| MINILED DENTALEZ OEM KIT | In distribution | |
| SP NEWTRON 4K5V | In distribution | |
| TIP PMS1 | In distribution | |
| PAM MINILED-N AF OEM ASS. FIN | In distribution | |
| TIP PFR | In distribution | |
| SP NEWTRON LED OEM CTRL | In distribution | |
| TIP ET20 | In distribution | |
| P5 XS 115V EMB FINAL | In distribution | |
| MF KIT NEWTRON ADEC 81″ MG V3 | In distribution | |
| NEWTR P5 B LED USA SS INSERTS | In distribution | |
| TIP AS9D | In distribution | |
| MODULE SP NEWTRON 4K5V CTRL | In distribution | |
| SP NEWTRON LED 4K5V DENTALEZ | In distribution | |
| NEWTRON P5 XS BLEB 300ml | In distribution | |
| ULTRAWAVE XS LED HAND PIECE | In distribution | |
| TIP PMV3 | In distribution | |
| TIP ASRD | In distribution | |
| BOX 4 FILES K10 LG 25 | In distribution | |
| TIP ET18D MORITA | In distribution | |
| KIT INTRO with Handpiece | In distribution | |
| KIT INTRO V3 | In distribution | |
| TIP PMV1 | In distribution | |
| BOX 4 FILES K15 LG 25 | In distribution | |
| MF KIT NEWT.LED ADEC 61″ MG V3 | In distribution | |
| TIP 10Z | In distribution | |
| NEWT BOOSTER HP NEWT. VET 115V | In distribution | |
| TIP ET25S | In distribution | |
| BOX 4 FILES K10 LG 21 | In distribution | |
| SP NEWTRON 4K3,7V US CTRL | In distribution | |
| BOX 4 FILES K10 LG25 MORITA | In distribution | |
| TIP H3 MORITA | In distribution | |
| NEWTRON MODULE 4K3.7V ADEC | In distribution | |
| SCANWAVE OEM PEN ASS FINAL | In distribution | |
| BOX 4 FILES K30 LG21 MORITA | In distribution | |
| PAM MINILED III SUPERCHARGED | In distribution | |
| TIP P15LD | In distribution | |
| PAM MINILED-N OEM SUPERCHARGED | In distribution | |
| NEWTRON MODULE 4K3.7V PLUG US | In distribution | |
| TIP P2L | In distribution | |
| TIP EX2 | In distribution | |
| NEWTRON P5 XS B LED CBVS | In distribution | |
| NEWTRON P5 XS BLED NO TIP CBVS | In distribution | |
| BOX 4 FILES K30 LG 25 | In distribution | |
| TIP SO4 MORITA | In distribution | |
| TIP CAP2 | In distribution | |
| SP NEWTRON USA CORDON F00184 | In distribution | |
| TIP PFL MORITA | In distribution | |
| BOX 4 FILES IRR K25 LG 25 | In distribution | |
| KIT ADEC SLIM LED GREY 3 – 61″ | In distribution | |
| BOX 4 TIPS PH2R | In distribution | |
| PAM MINILED SP NUE | In distribution | |
| TIP ET25 MORITA | In distribution | |
| NEWTRON MODULE 4K5V PLUG | In distribution | |
| MINILED OEM A-DEC 500 G3 V3 | In distribution | |
| TIP H4R | In distribution | |
| MODULE SP NEWTRON 4K5V II CTRL | In distribution | |
| TIP P15RD | In distribution | |
| TIP PMV6 | In distribution | |
| TIP PM2 | In distribution | |
| MINILED III SUPERCHARGED | In distribution | |
| TIP PMV5 | In distribution | |
| NEWTRON BOOSTER USA | In distribution | |
| TIP CAP1 | In distribution | |
| SP NEWTRON LED US LIGHT GREY | In distribution | |
| PAM ST GII R9002 & CG9C OEM | In distribution | |
| NEWT P5 B LED USA KIT INTRO V4 | In distribution | |
| KIT DETARTRAGE GII SS PAM | In distribution | |
| NEWTRON P5 BLED KIT V4 | In distribution | |
| TIP ET40D | In distribution | |
| PMAX XS 115V | In distribution | |
| NEWTR P5 B LED CBVS | In distribution | |
| ULTRAWAVE HAND PIECE | In distribution | |
| HANDPIECE STER SP NEWTRON SATELEC | In distribution | |
| TIP H2R | In distribution | |
| MODULE OEM MINILED EMBALLE | In distribution | |
| PAM MINILED AOC BLUERAY3 BLACK | In distribution | |
| TIP EXL | In distribution | |
| TIP ET25 | In distribution | |
| TIP EXR | In distribution | |
| TIP CAP3 | In distribution | |
| TIP TK2-1R | In distribution | |
| TIP PM4 | In distribution | |
| KIT ENDO SUCCESS RETREATEMENT | In distribution | |
| HANDPIECE NEWTRON SLIM | In distribution | |
| TIP ETPR | In distribution | |
| MINILED DENTALEZ OEM KIT | In distribution | |
| TIP P2R | In distribution | |
| NEWTRON BOOSTER VET | In distribution | |
| MF KIT NEWT. LED ADEC 61″AG V3 | In distribution | |
| KIT INTRO V4 | In distribution | |
| TIP TK1-1S | In distribution | |
| TIP ETBD | In distribution | |
| KIT PARO GII with Handpiece | In distribution | |
| MINILED III SUPERCHARGED | In distribution | |
| MINILED DENTALEZ OEM KIT | In distribution | |
| TIP PM1 | In distribution | |
| ULTRAWAVE P5 SS ACCESSOIRE | In distribution | |
| BOX 4 FILES K15 LG21 MORITA | In distribution | |
| NEWTRON LED MODULE 4K5V PLUG | In distribution | |
| TIP 1S MORITA | In distribution | |
| TIP 10P | In distribution | |
| NEWT BOOSTER CBVS HPNEWT NOTIP | In distribution | |
| TIP IP2L | In distribution | |
| TIP ET25L | In distribution | |
| HANDPIECE NEWTRON SLIM B.LED BC BT | In distribution | |
| KIT PERIOSOFT GII SS PAM | In distribution | |
| KIT PERFECT’MARGIN ROUNDED | In distribution | |
| PAM STER NG R9002 SATELEC | In distribution | |
| BOX 4 TIPS PH1 | In distribution | |
| KIT PMV | In distribution | |
| SP NEWT 4K3,7V V3 ADEC CTRL | In distribution | |
| PMAX XS 115V tips | In distribution | |
| TIP H1 | In distribution | |
| KIT PARO GII SS PAM | In distribution | |
| TIP 1S | In distribution | |
| TIP PMS2 | In distribution | |
| TIP EX1 | In distribution | |
| BOX 4 FILES IRR K20 LG 25 | In distribution | |
| KIT OEM NEWTRON LED VET | In distribution | |
| BOX 4 FILES K15 LG 21 | In distribution | |
| TIP ET20D | In distribution | |
| NEWT BOOSTER HP NEWT. US KITV4 | In distribution | |
| TIP P14D | In distribution | |
| BOX 4 FILES IRR K25 LG 21 | In distribution | |
| TIP 2 | In distribution | |
| PAM MINILED OEM BOUTONS GR NUE | In distribution | |
| BOX 4 FILES K25 LG 21 | In distribution | |
| P5 NEWTRON LED US | In distribution | |
| TIP IP3L | In distribution | |
| TIP H4L | In distribution | |
| TIP C20 | In distribution | |
| TIP 3 | In distribution | |
| BOX 4 FILES K15 LG25 MORITA | In distribution | |
| TIP AS6D | In distribution | |
| MINILED A-DEC 500 OEM KIT V3 | In distribution | |
| TIP TK2-1L | In distribution | |
| KIT EXCAVUS STD | In distribution | |
| TIP ET40D MORITA | In distribution | |
| KIT ADEC SLIM LED GREY 3 – 81″ | In distribution | |
| TIP H3 | In distribution | |
| TIP 1 MORITA | In distribution | |
| ULTRAWAVE XS LED | In distribution | |
| PAM MINILED BLACK ASS FINAL | In distribution | |
| TIP TK1-1L | In distribution | |
| KIT SP 4055 NEWT B.LED MORITA | In distribution | |
| SP NEWTRON ASI CD LG2.07 | In distribution | |
| P5 XS LED 115V | In distribution | |
| KIT INSERT CAP | In distribution | |
| TIP IP3R | In distribution | |
| PACK NEWTRON 2 LED NO TIPS | In distribution | |
| KIT PERIOSOFT GII with Handpiece | In distribution | |
| TIP S12-7D MORITA | In distribution | |
| TIP ET20 MORITA | In distribution | |
| TIP PFL | In distribution | |
| TIP AS3D | In distribution | |
| TIP ET40 MORITA | In distribution | |
| MINILED OEM MIDMARK | In distribution | |
| SP NEWTRON 4K3.7V US | In distribution | |
| TIP IP2R | In distribution | |
| KIT NEWTRON PARO | In distribution | |
| PAM ML OEM SUPERCHARGED EMB | In distribution | |
| TIP PFU MORITA | In distribution | |
| MF KIT NEWT. LED ADEC 81″MG V3 | In distribution | |
| BOX 4 FILES K30 LG25 MORITA | In distribution | |
| TIP PMV2 | In distribution | |
| SP NEWTRON 4K5V DENTALEZ | In distribution | |
| MINILED AF2 OEM ADEC 500 G3 V3 | In distribution | |
| KIT PMS | In distribution | |
| TIP ET20D MORITA | In distribution | |
| TIP ET18D | In distribution | |
| PAM MINILED OEM BOUT GRISE | In distribution | |
| BOX 4 FILES K25 LG 25 | In distribution | |
| TIP 5AE | In distribution | |
| SP NEWTRON LED LS PMAX XS CTRL | In distribution | |
| MF KIT NEWTRON ADEC 81″ AG V3 | In distribution | |
| TIP PFR MORITA | In distribution | |
| PAM MINILED AF | In distribution | |
| MF KIT NEWTRON ADEC 61″ MG V3 | In distribution | |
| TIP S12-70D | In distribution | |
| PAM MINILED-N ORTHO2 ASS.FINAL | In distribution | |
| TIP 10X | In distribution | |
| NEWTRON P5 XS B.LED KIT INTRO V4 | In distribution | |
| TIP IP1 | In distribution | |
| TIP PM3 | In distribution | |
| MINILED OEM CD P107 OPT OPA7.5 | In distribution | |
| BOX 4 FILES K30 LG 21 | In distribution | |
| MF KIT NEWTRON ADEC 61″ AG V3 | In distribution | |
| PRO-ULTRA NEWTRON 115V | In distribution | |
| MINILED AF US | In distribution | |
| KIT ENDO SUCCES API SURGERY | In distribution | |
| PAM LUMIERE A LEDS V3 SATELEC | In distribution | |
| PAM GRISE MINILED NUE STD | In distribution | |
| NEWT OEM KIT AG61 WITH HARNESS | In distribution | |
| BOX 4 FILES IRR K20 LG 21 | In distribution | |
| TIP P15LD MORITA | In distribution | |
| ML OEM SUPERCHARGED CD LG | In distribution | |
| P5 XS 115V +n°1-10Z-H3 | In distribution | |
| TIP TK1-1S MORITA | In distribution | |
| NEWT BOOSTER US HP NEWT NO TIP | In distribution | |
| TIP ETBD MORITA | In distribution | |
| P5 NEWTRON 115V | 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 |
| Mectron | Mectron SPA | 209 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060275 | 2006-05-03 |
| K050895 | 2005-04-20 |
| K033764 | 2004-03-01 |
| K972026 | 1997-07-09 |
| K961158 | 1996-05-23 |
| K942139 | 1995-09-29 |
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.