Lares Research
High-speed Handpiece, 757 ProStyle SF Lite, Swivel, Fiber optic, Ceramic, Morita Alpha connection
10manufacturers in China registered for this device type
130catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (7), Guangxi (1), Shaanxi (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
| Sinol Dental Limited | Xianyang | Shaanxi | Manufacturer | 5 |
| Foshan Soco Precision Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 4 |
| Shanghai Dental Instrument Factory Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Foshan Topmed Dental Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Foshan Wenjian Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Litu Tech Ltd. | Zhongshan | Guangdong | Manufacturer | 1 |
Record
| Listed by | Lares Research, United States |
|---|---|
| FDA product code | EFB |
| Device type | Handpiece, Air-Powered, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Remanufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K141221 |
| Record published | 2023-06-07 |
| Record revised | 2024-06-11 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: No special storage conditions |
| Sizes | Length 4.5 to 5 in |
| Distribution end date | 2024-10-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 757 ProStyle SF Lite SLC Morita Alpha | Length 4.5 in | In distribution |
| 557 ProStyle SF Lite | In distribution | |
| 557 ProStyle SF Lite 4HC | Length 4.5 in | In distribution |
| 757 ProStyle SF NSK SLC | In distribution | |
| MultiForce | In distribution | |
| 757 ProStyle SF Lite NSK SC | In distribution | |
| 757 ProStyle SF Legacy 5 | In distribution | |
| 557 ProStyle SF S FF Spain | In distribution | |
| 757 ProStyle SF Lite | In distribution | |
| 557 ProStyle SF | In distribution | |
| 757 ProStyle SF | In distribution | |
| Prophy, Pastel Plus 4H, GRN | Length 5 in | In distribution |
| Prophy, Pastel Plus 4H, PNK | Length 5 in | In distribution |
| L5 757 ProStyle SF SLC Morita Alpha | Length 4.5 in | In distribution |
| 557 ProStyle SF S FF | In distribution | |
| L5 757 ProStyle SF NSK SLC | In distribution | |
| 757 ProStyle SF Lite | In distribution | |
| 557 ProStyle SF Lite SLC, Morita Alpha | Length 4.5 in | In distribution |
| 557 ProStyle SF Lite | In distribution | |
| 757 ProStyle SF Lite SC Morita Alpha | Length 4.5 in | In distribution |
| 757 ProStyle SF Lite SLC Yoshida | Length 4.5 in | In distribution |
| Prophy, Pastel Plus 4H, SLVR | Length 5 in | In distribution |
| 757 ProStyle SF Legacy 5 | In distribution | |
| 757 ProStyle SF NSK SC | In distribution | |
| 757 ProStyle SF Lite | In distribution | |
| 557 ProStyle SF Legacy 5 | In distribution | |
| L5 557 ProStyle SF NSK SC | In distribution | |
| 757 ProStyle SF Lite SC Yoshida | Length 4.5 in | In distribution |
| 557 ProStyle SF S FF Portugal | In distribution | |
| 557 ProStyle SF Lite 4H LC | Length 4.5 in | In distribution |
| 757 ProStyle SF Lite | In distribution | |
| 557 ProStyle SF Lite SLC, Yoshida | Length 4.5 in | In distribution |
| 557 ProStyle SF S FF Columbia | In distribution | |
| 557 ProStyle SF Lite NSK SC | In distribution | |
| 557 ProStyle SF Lite NSK SLC | In distribution | |
| 557 ProStyle SF Legacy 5 | In distribution | |
| 757 ProStyle SF | In distribution | |
| Prophy, Pastel Plus 4H, BLU | Length 5 in | In distribution |
| L5 557 ProStyle SF NSK SLC | In distribution | |
| 757 ProStyle SF Lite NSK SLC | In distribution | |
| L5 757 ProStyle SF NSK SC | In distribution | |
| 557 ProStyle SF | In distribution | |
| 557 ProStyle SF NSK SLC | In distribution | |
| L5 557 ProStyle SF SLC Yoshida | Length 4.5 in | In distribution |
| 557 ProStyle SF NSK SC | In distribution | |
| 757 ProStyle SF Lite | Withdrawn | |
| 557 ProStyle SF Lite | Withdrawn | |
| Prophy, Pastel Plus | Withdrawn | |
| 757 ProStyle SF Lite 4H | Length 4.5 in | Withdrawn |
| 757 ProStyle SF | Withdrawn | |
| 757 ProStyle SF Lite SC | Length 4.5 in | Withdrawn |
| L5 557 ProStyle SF SC | Length 4.5 in | Withdrawn |
| LSPD ValueTorque LATCH HEAD | Length 5 in | Withdrawn |
| VALUETORQUE LATCH HEAD | Withdrawn | |
| 757 ProStyle SF Lite 4HC | Length 4.5 in | Withdrawn |
| LSPD ValueTorque 1:1 STRAIGHT Attachment | Length 5 in | Withdrawn |
| 557 ProStyle SF SC | Length 4.5 in | Withdrawn |
| 557 ProStyle SF | Withdrawn | |
| LSPD VT 4:1 CNTRA ANGL W/O HEAD | Length 5 in | Withdrawn |
| 557 PROSTYLE SF | Withdrawn | |
| LSPD ValueTorque 0-20k RPM ST SW, 4H | Length 5 in | Withdrawn |
| lLSPD VT 1:1 CNTRA ANGLE W/O HEAD | Length 5 in | Withdrawn |
| Kent Dental 557 ProStyle SF SLC | Length 4.5 in | Withdrawn |
| L5 557 ProStyle SF | Withdrawn | |
| 557 ProStyle SF Lite SLC | Length 4.5 in | Withdrawn |
| LSPD ValueTorque 0-5k RPM ST HP, SW | Length 5 in | Withdrawn |
| 757 ProStyle SF Lite | Withdrawn | |
| CA,ProStyle E, 1:1,PB,Latch, Classic | Withdrawn | |
| 757 ProStyle SF Lite | Withdrawn | |
| 757 ProStyle SF SC | Length 4.5 in | Withdrawn |
| 757 ProStyle SF | Withdrawn | |
| 757 ProStyle SF SLC | Length 4.5 in | Withdrawn |
| 557 ProStyle SF Lite | Withdrawn | |
| 557 ProStyle SF Lite S | Length 4.5 in | Withdrawn |
| L5 757 ProStyle SF SLC | Length 4.5 in | Withdrawn |
| Prophy, Pastel Plus | Withdrawn | |
| 557 ProStyle SF Lite SC | Length 4.5 in | Withdrawn |
| L5 757 ProStyle SF SC | Length 4.5 in | Withdrawn |
| CA,ProStyle E, 1:5,PB,FG, Classic | Withdrawn | |
| LSPD ValueTorque 0-5k RPM ST HP, 4H | Length 5 in | Withdrawn |
| R & S 757 ProStyle SF SLC | Length 4.5 in | Withdrawn |
| 757 ProStyle SF Lite | Withdrawn | |
| 557 ProStyle SF Lite | Withdrawn | |
| Prophy, Pastel Plus | Withdrawn | |
| 757 ProStyle SF | Withdrawn | |
| 757 ProStyle SF Lite | Withdrawn | |
| 757 ProStyle SF Lite | Withdrawn | |
| 557 ProStyle SF Lite 4H L | Length 4.5 in | Withdrawn |
| 757 ProStyle SF Lite SL | Length 4.5 in | Withdrawn |
| LSPD 0-5K Straight, MultiForce | Withdrawn | |
| 557 ProStyle SF Lite | Withdrawn | |
| 557 ProStyle SF Lite | Withdrawn | |
| 557 ProStyle SF Lite | Withdrawn | |
| 757 ProStyle SF Lite SLC | Length 4.5 in | Withdrawn |
| Straight,ProStyle E, 1:1,Attachment | Withdrawn | |
| L5 757 ProStyle SF | Withdrawn | |
| CA, ProStyle E, 1:1, PB,Latch, Micro | Withdrawn | |
| 557 ProStyle SF SLC | Length 4.5 in | Withdrawn |
| 757 ProStyle SF Lite | Withdrawn | |
| L5 557 ProStyle SF | Withdrawn | |
| 557 PROSTYLE SF LITE | Withdrawn | |
| 757 ProStyle SF SL | Length 4.5 in | Withdrawn |
| 330E | Length 4.5 in | Withdrawn |
| R & S 557 ProStyle SF SLC | Length 4.5 in | Withdrawn |
| L5 757 ProStyle SF | Withdrawn | |
| LSPD ValueTorque 4:1 STRAIGHT Attachment | Length 5 in | Withdrawn |
| 557 ProStyle SF Lite 4H | Length 4.5 in | Withdrawn |
| LSPD ValueTorque 0-20k RPM ST 4HW, 4H | Length 5 in | Withdrawn |
| Kent Dental 757 ProStyle SF SLC | Length 4.5 in | Withdrawn |
| 757 ProStyle SF Lite | Withdrawn | |
| 557 ProStyle SF | Withdrawn | |
| 757 ProStyle SF | Withdrawn | |
| 757 ProStyle SF Lite | Withdrawn | |
| 557 ProStyle SF Lite 2H | Length 4.5 in | Withdrawn |
| 557 ProStyle SF Lite SL | Length 4.5 in | Withdrawn |
| CA,ProStyle E, 1:5,PB,FG, Micro | Withdrawn | |
| 757 ProStyle SF Lite 4H LC | Length 4.5 in | Withdrawn |
| 757 ProStyle SF S | Length 4.5 in | Withdrawn |
| 557 ProStyle SF S | Length 4.5 in | Withdrawn |
| 757 ProStyle SF Lite 4H L | Length 4.5 in | Withdrawn |
| 757 ProStyle SF Lite S | Length 4.5 in | Withdrawn |
| 757 ProStyle SF Lite | Withdrawn | |
| 757 ProStyle SF Lite | Withdrawn | |
| Prophy, Pastel Plus | Withdrawn | |
| 557 ProStyle SF SL | Length 4.5 in | Withdrawn |
| 557 ProStyle SF | Withdrawn | |
| LSPD ValueTorque PROPHY HEAD | Length 5 in | Withdrawn |
| 557 ProStyle SF Lite | Withdrawn | |
| 557 ProStyle SF Lite | Withdrawn | |
| L5 557 ProStyle SF SLC | Length 4.5 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AIR-Flow | E.M.S. Electro Medical Systems S.A. | 220 |
| MK-dent | MK-dent GmbH | 129 |
| Vector R&D, Inc | Vector R&D, Inc. | 114 |
| MK-dent Germany® | MK-dent GmbH | 112 |
| Johnson-Promident | Young Innovations Inc. | 92 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 76 |
| Airlight | Beyes Dental Canada, Inc. | 65 |
| Henry Schein | Henry Schein, Inc. | 62 |
| MicroP Dental | Microp Technology (Taiwan), Inc. | 51 |
| StarDental Instrument Solutions | Dentalez, Inc. | 47 |
| Air-Driven Dental Handpieces | MDK Co., Ltd. | 39 |
| Maxso | Beyes Dental Canada, Inc. | 38 |
Showing 12 of 968. All products under Handpiece, Air-Powered, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141221 | 2014-10-28 |
| K961163 | 1996-04-23 |
| K905542 | 1991-03-11 |
| K905541 | 1991-03-07 |
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.