Piezon
PIEZON 150 is an ultrasonic scaler used by a dentist or dental hygienist. The FDA filing says it delivers ultrasonic movement and water to a stainless steel tip. The stated uses include…
PIEZON 150 is an ultrasonic scaler used by a dentist or dental hygienist. The FDA filing says it delivers ultrasonic movement and water to a stainless steel tip.
The stated uses include periodontal pocket lavage with simultaneous ultrasonic tip movement, scaling and root planing, and removal of supra and subgingival calculus and stains from teeth.
Listed Item
The Piezon handpiece is an accessory in the Piezo-ceramic systems for dentistry.
Water and Controls
The control unit connects to an external water supply and delivers water through the connected handpiece. The filing describes power adjustment with a knob on top of the unit and irrigating-liquid flow adjustment with a side knob.
14manufacturers in China registered for this device type
245catalogue numbers in this listing
10510(k) clearances naming this product code
3recalls on this 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 | E.M.S. Electro Medical Systems S.A., Switzerland |
|---|---|
| FDA product code | ELC |
| Device type | Scaler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4850 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K132443 |
| Record published | 2018-12-05 |
| Record revised | 2020-07-07 (version 5) |
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 | Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 75 % RH; Storage environment temperature -10 to 40 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Packaging | Pack of 3 |
| Sizes | Outer diameter 0.15 to 0.35 mm |
| Distribution end date | 2017-12-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| E | In distribution | ||
| DS-084A/T/A | In distribution | ||
| FT-223#C/001 | In distribution | ||
| DS-001A/A | In distribution | ||
| EN-061#E/001 | In distribution | ||
| FT-223#C/002 | In distribution | ||
| b | In distribution | ||
| a | In distribution | ||
| c | In distribution | ||
| a | In distribution | ||
| c | In distribution | ||
| A | In distribution | ||
| A | In distribution | ||
| g | In distribution | ||
| a | In distribution | ||
| d | In distribution | ||
| a | In distribution | ||
| FT-224MI | In distribution | ||
| FT-223#B/001 | In distribution | ||
| a | In distribution | ||
| DT-065A | In distribution | ||
| FT-215/HF | In distribution | ||
| FT-223#B | In distribution | ||
| a | In distribution | ||
| b | In distribution | ||
| DS-001A/T | In distribution | ||
| d | In distribution | ||
| B | In distribution | ||
| FT-223#B/007 | In distribution | ||
| DS-084A/T | In distribution | ||
| B | In distribution | ||
| DS-010A | In distribution | ||
| B | In distribution | ||
| k | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| b | In distribution | ||
| A-01 | In distribution | ||
| b | In distribution | ||
| B | In distribution | ||
| a | In distribution | ||
| C | In distribution | ||
| A | In distribution | ||
| DS-016OS | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| c | In distribution | ||
| b | Outer Diameter 0.15 mm | In distribution | |
| E | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| D | In distribution | ||
| FT-223#C | In distribution | ||
| f | In distribution | ||
| FS-455 | In distribution | ||
| B | In distribution | ||
| FT-223#B/005 | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| DS-001A/B | In distribution | ||
| a | In distribution | ||
| C | In distribution | ||
| FT-216W | In distribution | ||
| c | In distribution | ||
| a | In distribution | ||
| e | In distribution | ||
| FT-223#B/002 | In distribution | ||
| FS-462HF | In distribution | ||
| a | In distribution | ||
| FS-455 | In distribution | ||
| a | In distribution | ||
| EN-037 | In distribution | ||
| B | In distribution | ||
| DS-016A/B | In distribution | ||
| E | In distribution | ||
| b | In distribution | ||
| B | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| A | In distribution | ||
| F | In distribution | ||
| E | In distribution | ||
| FS-455HF | In distribution | ||
| j | In distribution | ||
| A | In distribution | ||
| D | In distribution | ||
| E | In distribution | ||
| E | In distribution | ||
| DS-084A/A | In distribution | ||
| a | In distribution | ||
| c | In distribution | ||
| EN-060#B/001 | In distribution | ||
| D | In distribution | ||
| DS-083A/B | In distribution | ||
| G | In distribution | ||
| A | In distribution | ||
| c | In distribution | ||
| a | In distribution | ||
| B | In distribution | ||
| a | In distribution | ||
| 1 | In distribution | ||
| H | In distribution | ||
| EN-060#MX | In distribution | ||
| F | In distribution | ||
| c | In distribution | ||
| C | In distribution | ||
| A | In distribution | ||
| a | In distribution | ||
| F | In distribution | ||
| a | In distribution | ||
| e | In distribution | ||
| C | In distribution | ||
| K | In distribution | ||
| DS-084A/B | In distribution | ||
| DS-016A/A | In distribution | ||
| A | In distribution | ||
| B | In distribution | ||
| EN-037#C/008 | In distribution | ||
| D | In distribution | ||
| b | Outer Diameter 0.25 mm | In distribution | |
| b | Outer Diameter 0.30 mm | In distribution | |
| DS-011A/B | In distribution | ||
| c | In distribution | ||
| FT-223#C/003 | In distribution | ||
| A | In distribution | ||
| b | Outer Diameter 0.20 mm | In distribution | |
| A | In distribution | ||
| DS-011A/A | In distribution | ||
| DS-011A/T | In distribution | ||
| E | In distribution | ||
| e | In distribution | ||
| g | In distribution | ||
| b | Outer Diameter 0.35 mm | In distribution | |
| EN-041#A/001 | In distribution | ||
| a | In distribution | ||
| C | In distribution | ||
| g | In distribution | ||
| A | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| D | In distribution | ||
| C | In distribution | ||
| a | In distribution | ||
| DS-011A/A | In distribution | ||
| F | In distribution | ||
| H | In distribution | ||
| B | In distribution | ||
| a | In distribution | ||
| C | In distribution | ||
| FT-223#B/004 | In distribution | ||
| q | In distribution | ||
| DS-010A | In distribution | ||
| FS-461 | In distribution | ||
| EN-037#C/001 | In distribution | ||
| D | In distribution | ||
| DS-016A/T/A | In distribution | ||
| c | In distribution | ||
| B | In distribution | ||
| EN-037#C/007 | In distribution | ||
| a | In distribution | ||
| G | In distribution | ||
| A | In distribution | ||
| a | In distribution | ||
| A | In distribution | ||
| A | In distribution | ||
| c | In distribution | ||
| A | In distribution | ||
| a | In distribution | ||
| b | In distribution | ||
| FT-216HF/HF | In distribution | ||
| a | In distribution | ||
| FS-462HF | In distribution | ||
| DS-083A/T | In distribution | ||
| b | In distribution | ||
| c | In distribution | ||
| a | In distribution | ||
| B | In distribution | ||
| a | In distribution | ||
| c | In distribution | ||
| G | In distribution | ||
| DS-003A | In distribution | ||
| DS-001A/T/A | In distribution | ||
| a | In distribution | ||
| L | In distribution | ||
| M | In distribution | ||
| B | In distribution | ||
| a | In distribution | ||
| B | In distribution | ||
| A | In distribution | ||
| a | In distribution | ||
| E | In distribution | ||
| FS-500 | In distribution | ||
| a | In distribution | ||
| c | In distribution | ||
| a | In distribution | ||
| c | In distribution | ||
| d | In distribution | ||
| B | In distribution | ||
| b | In distribution | ||
| a | In distribution | ||
| DS-083A/T/A | In distribution | ||
| a | In distribution | ||
| DS-001OS | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| a | In distribution | ||
| d | In distribution | ||
| FT-224#B/002 | In distribution | ||
| FT-223#B/006 | In distribution | ||
| m | In distribution | ||
| c | In distribution | ||
| a | In distribution | ||
| b | In distribution | ||
| a | In distribution | ||
| A | In distribution | ||
| b | In distribution | ||
| FT-223#B/003 | In distribution | ||
| F | In distribution | ||
| FS-462 | In distribution | ||
| F | In distribution | ||
| a | In distribution | ||
| B | In distribution | ||
| DS-011A/T/A | In distribution | ||
| N | In distribution | ||
| DS-010A/B | In distribution | ||
| DS-083A/A | In distribution | ||
| a | In distribution | ||
| DT-065A | In distribution | ||
| a | In distribution | ||
| E | In distribution | ||
| c | In distribution | ||
| C | In distribution | ||
| a | In distribution | ||
| c | In distribution | ||
| FS-436HF | In distribution | ||
| DS-016A/T | 3 | In distribution | |
| C | Withdrawn | ||
| B | Withdrawn | ||
| A | Withdrawn | ||
| C | Withdrawn | ||
| B | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 501 |
| Acteon | Satelec | 236 |
| 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 |
|---|---|
| K253254 | 2026-01-28 |
| K190124 | 2019-10-20 |
| K191079 | 2019-08-16 |
| K140990 | 2015-02-27 |
| K132445 | 2013-12-06 |
| K132443 | 2013-11-22 |
| K110173 | 2011-04-07 |
| K093723 | 2010-09-08 |
| K093000 | 2010-07-30 |
| K050710 | 2005-03-30 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| E.M.S. Electro Medical Systems S.A. | 510(k) number | 2024-03-13 | Class II | Process control | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles). | 342 |
| E.M.S. Electro Medical Systems S.A. | 510(k) number | 2024-03-13 | Class II | Process control | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles). | 462 |
| E.M.S. Electro Medical Systems S.A. | 510(k) number | 2024-03-13 | Class II | Process control | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles). | 54 |
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.