Osstell Beacon Instrument
Osstell Beacon is a handheld instrument for measuring dental implant stability in the oral cavity and maxillofacial region. It uses resonance-frequency analysis and displays the result as…
Osstell Beacon is a handheld instrument for measuring dental implant stability in the oral cavity and maxillofacial region. It uses resonance-frequency analysis and displays the result as an Implant Stability Quotient.
A small aluminium Smartpeg is screwed onto the implant. The instrument’s measurement tip excites it with a magnetic pulse and analyses the response to calculate its resonance frequency, from which the stability quotient is derived.
Handling Conditions
The instrument must be used with a transparent barrier sleeve and cannot be autoclaved. It does not measure while charging. Bluetooth supports data communication.
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jung Chen Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 2 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| 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 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Changzhou Sifary Medical Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Shenzhen Perfect Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 10 |
| Changzhou Bomedent Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
Record
| Listed by | Osstell AB, Sweden |
|---|---|
| FDA product code | EKX |
| Device type | Handpiece, Direct Drive, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Manufacturer |
| 510(k) | K181888 |
| Record published | 2025-09-26 |
| Record revised | 2024-09-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Packaging | Box, box demo |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Osstell Beacon Instrument | In distribution | |
| Osstell Osstell Beacon Instrument | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MulTipeg™ | Integration Diagnostics Sweden AB | 151 |
| Aseptico | Aseptico, Inc. | 40 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 26 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 16 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 16 |
| Delfin2 | Intra-Lock International | 16 |
| Ultrapro TX Cordless | Ultradent Products Inc. | 13 |
| CanalPro | Coltene/Whaledent Gmbh & Co. KG | 12 |
| ChecQPEG | Dentis Co., Ltd. | 12 |
| EdgeApex HP™ | US Endodontics, LLC | 11 |
| Penguin RFA | Integration Diagnostics Sweden AB | 10 |
| Henry Schein | Henry Schein, Inc. | 9 |
Showing 12 of 307. All products under Handpiece, Direct Drive, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181888 | 2019-08-22 |
| K142358 | 2015-02-19 |
| K132401 | 2014-04-09 |
| K082523 | 2008-09-26 |
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.