American Eagle Instruments
Scaler Nebraska 128 (SE) XPE (3/8) Orange
Who Else Makes It
Concentrated in Guangdong (15), Shandong (5), Shanghai (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Yangzhou Haiwang Toothbrush Factory | Yangzhou | Jiangsu | Contract manufacturer | 12 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Perfect Group Corp. Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
Showing 12 of 34. All 34 manufacturers in China registered for Scaler, Periodontic
Record
| Listed by | American Eagle Instruments, United States |
|---|---|
| FDA product code | EMN |
| Device type | Scaler, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-23 |
| Record revised | 2024-04-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-04-12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AESH6-7XPX | In distribution | |
| AES311-312XPXE | In distribution | |
| AESH6-7XPXE | In distribution | |
| AESETXPZ | In distribution | |
| AESONEBXPQTE | In distribution | |
| AESM23TXPX-GC | In distribution | |
| AESJ3-4Z | In distribution | |
| AESJ3-U15X | In distribution | |
| AESU15S | In distribution | |
| AESJ3-U15Z | In distribution | |
| AESETBXPQT | In distribution | |
| AESM23BVXPQT | In distribution | |
| ML5-U5Z | In distribution | |
| AESJ3-U15XPX | In distribution | |
| AES204SDXPZ | In distribution | |
| AESBJAXPQT | In distribution | |
| AESH5-33Z | In distribution | |
| AESM23ATTQT | In distribution | |
| AESBJVXPX | In distribution | |
| AESH6-7S | In distribution | |
| AES204SAXPQTE | In distribution | |
| MJ14-15Z | In distribution | |
| AESH6-7X | In distribution | |
| MU5-U5X | In distribution | |
| AES312XPQTE | In distribution | |
| AESH5VXPQT | In distribution | |
| AES2YS-3YSZ | In distribution | |
| AES311XPQT | In distribution | |
| AESHO18-19X | In distribution | |
| AEIDEMOKIT | In distribution | |
| AES311-312XPZ | In distribution | |
| AESM23XPZ | In distribution | |
| AESB7-8X | In distribution | |
| M311-312X | In distribution | |
| AESN137X | In distribution | |
| AESN128DEX | In distribution | |
| AESN128DEXPXE | In distribution | |
| AESN1AXPQTE | In distribution | |
| AESECXPXE | In distribution | |
| AESM23AVXPQT | In distribution | |
| AESU15-30X | In distribution | |
| AESZS | In distribution | |
| MH6-7X | In distribution | |
| AESH6-7Z | In distribution | |
| AESM23TXPX | In distribution | |
| AESHO20-21X | In distribution | |
| AESBJXPZ | In distribution | |
| AES311-312Z | In distribution | |
| AESB513BXPQTE | In distribution | |
| AESB7-8Z | In distribution | |
| AESECZ | In distribution | |
| AES204SBXPQTE | In distribution | |
| AESM23X | In distribution | |
| AESN128XPQT | In distribution | |
| AESCK6Z | In distribution | |
| AESM23XPX | In distribution | |
| AESECAXPQTE | In distribution | |
| AESH7TTQT | In distribution | |
| AESJ4-U5S | In distribution | |
| MU15-33X | In distribution | |
| AESJ4-U5L | In distribution | |
| AESB513XPXE | In distribution | |
| GCIIL3-4X | In distribution | |
| AESBJTBXPQT | In distribution | |
| AESETAXPQTE | In distribution | |
| MJ3-U5X | In distribution | |
| AESN1AXPQT | In distribution | |
| AES204SDBXPQT | In distribution | |
| AESM23AXPQT | In distribution | |
| AESBJBXPQTE | In distribution | |
| AES204SX | In distribution | |
| AES311-312XPX | In distribution | |
| AES204SXPXE | In distribution | |
| AESJ4-U5Z | In distribution | |
| AES311-312X | In distribution | |
| AESH6XPQT | In distribution | |
| AESJ3-U5X | In distribution | |
| AESBJATTQT | In distribution | |
| AESU15-33XPZ | In distribution | |
| AESH6-7VXPX | In distribution | |
| AESN128XPX | In distribution | |
| AESJ31-32Z | In distribution | |
| AESM23TXPZ | In distribution | |
| AESJ3-U15XPXE | In distribution | |
| AESJ3-U5XPXE | In distribution | |
| ML5-U5X | In distribution | |
| AESM23BTTQT | In distribution | |
| AESETXPX | In distribution | |
| AESM23TAXPQTE | In distribution | |
| AESN1BXPQT | In distribution | |
| AESONEXPXE | In distribution | |
| AESN3X | In distribution | |
| AESH6TTQT | In distribution | |
| AES33XPQTE | In distribution | |
| AES204SBXPQT | In distribution | |
| M311-312Z | In distribution | |
| AESJ3-U5XPX | In distribution | |
| M204SZ | In distribution | |
| AES204SXPZ | In distribution | |
| AESCK6X | In distribution | |
| AESSD11-12X | In distribution | |
| AES204SDXPX | In distribution | |
| MU15-30Z | In distribution | |
| AESECBXPQTE | In distribution | |
| AESECXPX | In distribution | |
| AESN128DEXPZ | In distribution | |
| AESBJBXPQT | In distribution | |
| AESH7XPQT | In distribution | |
| AESJ14-15X | In distribution | |
| AESBJAVXPQT | In distribution | |
| AESJ3-U5Z | In distribution | |
| AEIIN128-L5X | In distribution | |
| AESN135X | In distribution | |
| AESBJZ | In distribution | |
| AESH5-33X | In distribution | |
| AESB513AXPQTE | In distribution | |
| MN128DEX | In distribution | |
| AESU5S | In distribution | |
| AESN137XPZ | In distribution | |
| AESH7VXPQT | In distribution | |
| AESJ3-U15L | In distribution | |
| AESBJTXPXE | In distribution | |
| AESM23VXPX | In distribution | |
| AES204SAXPQT | In distribution | |
| AESETBXPQTE | In distribution | |
| AESECATTQT | In distribution | |
| AESECAXPQT | In distribution | |
| AESN1BXPQTE | In distribution | |
| AESN3Z | In distribution | |
| AESJ14-15L | In distribution | |
| AES33TTQT | In distribution | |
| AESM23AXPQTE | In distribution | |
| AES2YS-3YSX | In distribution | |
| AES204SDXPXE | In distribution | |
| AESM23TX | In distribution | |
| MH5-33X | In distribution | |
| AESBJAXPQTE | In distribution | |
| AESH6XPQTE | In distribution | |
| AESJ4-U5X | In distribution | |
| AESETAXPQT | In distribution | |
| AES204SDZ | In distribution | |
| AESU15-33X | In distribution | |
| MJ14-15X | In distribution | |
| AES107-108Z | In distribution | |
| M204SX | In distribution | |
| AESJ14-15XPX | In distribution | |
| AESM23Z | In distribution | |
| AESN2XPX | In distribution | |
| AESU15-30XPXE | In distribution | |
| AES204SDATTQT | In distribution | |
| AESH5-33XPXE | In distribution | |
| AES107-108X | In distribution | |
| AESJ4-U15X | In distribution | |
| AESH6-7L | In distribution | |
| AES204SATTQT | In distribution | |
| AESN2X | In distribution | |
| AESH6-7XPZ | In distribution | |
| AES204SDBXPQTE | In distribution | |
| AES312XPQT | In distribution | |
| AESH5-33XPX | In distribution | |
| AESB513XPZ | In distribution | |
| AESN135Z | In distribution | |
| AESM23BXPQTE | In distribution | |
| M204SDZ | In distribution | |
| AESN2XPZ | In distribution | |
| AESU15X | In distribution | |
| AESETZ | In distribution | |
| AESH5XPQTE | In distribution | |
| AES11-12SX | In distribution | |
| AESN1Z | In distribution | |
| AESM23TXPXE | In distribution | |
| AESN1XPZ | In distribution | |
| MJ3-U5Z | In distribution | |
| AESN1X | In distribution | |
| AESU15-30XPX | In distribution | |
| AESN128S | In distribution | |
| AESBJTAXPQT | In distribution | |
| AESB513XPX | In distribution | |
| AES204SBTTQT | In distribution | |
| AESN128X | In distribution | |
| AES204SDAXPQT | In distribution | |
| AES312TTQT | In distribution | |
| AESBJTBXPQTE | In distribution | |
| MU15-33Z | In distribution | |
| AESN137Z | In distribution | |
| AESJ4-U5XPXE | In distribution | |
| AES204SZ | In distribution | |
| AESECBTTQT | In distribution | |
| AESB513BXPQT | In distribution | |
| AESM23TAXPQT | In distribution | |
| AESJ14-15XPZ | In distribution | |
| AESN128XPXE | In distribution | |
| AESBJBTTQT | In distribution | |
| GCII204SX | In distribution | |
| AESH6VXPQT | In distribution | |
| AES204SDX | In distribution | |
| AESU15-30XPZ | In distribution | |
| AESN128TTQT | In distribution | |
| AESN1XPXE | In distribution | |
| AESHO18-19Z | In distribution | |
| AESJ4-U15Z | In distribution | |
| MM0-00X | In distribution | |
| AESU15-33XPX | In distribution | |
| AESECX | In distribution | |
| AESN128XPZ | In distribution | |
| AESM0-00Z | In distribution | |
| AESJ3-U15XPZ | In distribution | |
| AESBJXPXE | In distribution | |
| AESECBXPQT | In distribution | |
| AESM23XPXE | In distribution | |
| AESBJBVXPQT | In distribution | |
| AESONEAXPQTE | In distribution | |
| AESJ3-U5XPZ | In distribution | |
| AESH5-33L | In distribution | |
| AESJ14-15Z | In distribution | |
| GCIIN128-L5X | In distribution | |
| AESBJXPX | In distribution | |
| AESETX | In distribution | |
| AESN1XPX | In distribution | |
| AESJ4-U5XPZ | In distribution | |
| AESN128DEZ | In distribution | |
| AESBJTXPX | In distribution | |
| AES311TTQT | In distribution | |
| AESH5XPQT | In distribution | |
| AESBJTAXPQTE | In distribution | |
| AESB513AXPQT | In distribution | |
| AESU5-U5X | In distribution | |
| MN128DEZ | In distribution | |
| MM0-00Z | In distribution | |
| MU5-U5Z | In distribution | |
| AES204SDBTTQT | In distribution | |
| AESH5-33XPZ | In distribution | |
| AESH5-33VXPX | In distribution | |
| AES311XPQTE | In distribution | |
| AES204SDAXPQTE | In distribution | |
| AESBJX | In distribution | |
| AESM0-00X | In distribution | |
| AESH7XPQTE | In distribution | |
| MM23X | In distribution | |
| AESN128DEXPX | In distribution | |
| AESN2XPXE | In distribution | |
| AESM23TBXPQT | In distribution | |
| AESETATTQT | In distribution | |
| AESM23TBXPQTE | In distribution | |
| AESN137XPXE | In distribution | |
| M204SDX | In distribution | |
| M5-CARVE | In distribution | |
| AESU15-30Z | In distribution | |
| AESH5-33S | In distribution | |
| AESM23BXPQT | In distribution |
Showing 250 of 269 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 468 |
| Zoll-Dental | Zoll-Dental | 255 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 207 |
| Power Dental USA | Power Dental U.S.A. Inc. | 202 |
| Osung MND | Osung MND Co., Ltd. | 102 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 85 |
| Sklar® | Sklar Corporation | 81 |
| Henry Schein | Henry Schein, Inc. | 79 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 77 |
| PDT, Inc. | PDT, Inc. | 67 |
| House Brand Dentistry | Frontier Dental Supply Inc | 65 |
| J & J Instruments | J & J Instruments, LLC | 56 |
Showing 12 of 216. All products under Scaler, Periodontic
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.