Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027615

FEI Number

1000127001

Entity Name

AMERICAN EAGLE INSTRUMENTS

City/State/Country

Missoula, MT, US

Establishment Address

6575 BUTLER CREEK RD., Missoula, MT 59808, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Young Innovations Inc (Owner Number: 9004980)

Owner / Operator Contact Address

2260 Wendt street, Algonquin, IL 60102, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Surgical Instruments - Hand Instrument DEL ULTRASONIC TIPS AEI Surgical Instruments Dental Rongeurs Surgical Instruments - Scalpel Surgical Instruments - Curette Surgical Instruments - Chisel AEI Quik Tip Handles AEI Mirror Handles Diamond Coated Tip AEI Excavators Surgical Instruments - Forceps Kerr Ultrasonic TIps AEI Burnishers DG-16 Endo Explorer CX-1 Carr Explorer AEI Pluggers Surgical Instruments - Knife AEI Blackjack (XP) AEI Montana Value AEI XP Technology AEI Quik Tips AEI Talon Tough Ligature Tucking Instruments Band Pushers AEI Dental Hand Instruments Surgical Instruments - Scissors AEI Carvers Surgical Instruments - Retractor AEI Spreaders AEI Quik Tips AEI Double Graceys AEI Scandette AEI XP Technology AEI Implant Instruments AEI Talon Tough

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2019-07-23
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2013-04-08
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2026-06-01
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2025-12-18
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2025-12-18
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2025-12-18
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	1992-09-16
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2024-10-07
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2022-10-14
EFL	Forceps, Dressing, Dental	Dental	Class 1	872.4565	2025-12-18
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2025-08-21
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2022-10-14
EKB	Explorer, Operative	Dental	Class 1	872.4565	2016-01-12
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	1992-09-16
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2012-12-31
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2012-12-31
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2022-02-21
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2012-12-31
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	2019-07-23
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	1992-09-16
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2025-12-18
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	2012-12-31
EMS	Curette, Periodontic	Dental	Class 1	872.4565	1992-09-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Young Innovations Inc

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2134751	YOUNG MICROBRUSH LLC	GRAFTON, WI, US
8022249	GERMIPHENE CORP.	BRANTFORD Ontario, CA
1941138	YOUNG DENTAL MANUFACTURING CO 1, LLC.	EARTH CITY, MO, US
2024980	YOUNG INNOVATIONS INC.	Algonquin, IL, US
1066741	SALVIN DENTAL SPECIALTIES, LLC	CHARLOTTE, NC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K832443	California Technics, Inc.	ULTRASONIC DENTAL PROPHYLAXIS UNIT	1983-09-12
K994299	Bonart Co., Ltd.	ART-P3, MODEL P3-1-ART-A1	2000-03-06
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K821275	Conphar, Inc.	MAYO SCISSOR STRAIGHT 5 1/2	1982-05-28
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0039-2018	Teleflex Medical	1	Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

Registration Number	Establishment Name	Location
1032227	BRASSELER U.S.A. DENTAL, LLC	SAVANNAH, GA, US
3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
9681540	ULTRA SURGICAL (PVT.) LTD	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027615. Last updated year: 2026. Please use registration number 3027615 when referencing this establishment in official correspondence.