American Eagle Instruments

Scaler Nebraska 128 (SE) XPE (3/8) Orange

Registry build 21.09.26
34manufacturers in China registered for this device type
269catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code EMN
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

Regulatory record for American Eagle Instruments
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

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 numbers for American Eagle Instruments
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer