FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013105043
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEEXC78-79
Catalog number
AEEXC78-79
Device description
EXCAVATOR 78-79
Published
2022-07-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMOKNIFE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMOKnife, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841013105043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013105043008410131050438410131050430841013105043

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 551 5172customerservice@am-eagle.com

Regulatory Flags#

DUNS number
790776850
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841013124761American Eagle InstrumentsAEC1/4DINAEC1/4DIN 2026-02-12
00841013124778American Eagle InstrumentsAEC1/2DINAEC1/2DIN2026-02-12
00841013124785American Eagle InstrumentsAESCDINAESCDIN2026-02-12
00841013124792American Eagle InstrumentsAESCCONAESCCON2026-02-12
00841013124808American Eagle InstrumentsAECAGRAILAECAGRAIL2026-02-12
00841013124815American Eagle InstrumentsAECRAILAECRAIL2026-02-12
00841013124822American Eagle InstrumentsAECCRAILAECCRAIL2026-02-12
00841013124839American Eagle InstrumentsAESCLIPSAESCLIPS2026-02-12
00841013124846American Eagle InstrumentsAESCLIPNHAESCLIPNH2026-02-12
00841013124853American Eagle InstrumentsAESCTOOLAESCTOOL2026-02-12
00841013120459Otto LeibingerAESH512026-01-06
00841013120466Otto LeibingerAESH51E2026-01-06
00841013120473Otto LeibingerAESPUNC152026-01-06
00841013120480Otto LeibingerAESSH52026-01-06
00841013120497Otto LeibingerAESPPR3S2026-01-06
00841013120503Otto LeibingerAESPGSP2026-01-06
00841013120510Otto LeibingerAESPGF142026-01-06
00841013120527Otto LeibingerAESPP9PA2026-01-06
00841013120534Otto LeibingerAESPWI062026-01-06
00841013120541Otto LeibingerAESPBU2026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840018674011Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-11
00840018666009Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-09
00840018663367Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMO2026-02-04
D928400101CH0PERIO KNIFE GOLDMAN FOX 8 CH HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102CH0PERIO KNIFE GOLDMAN FOX 11 CH HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102HF0PERIO KNIFE GOLDMAN FOX 11 HF HANDLEW.H. Holden, Inc.EMO2026-01-14
D928400102R0PERIO KNIFE GOLDMAN FOX 11 ROUND HANDLEW.H. Holden, Inc.EMO2026-01-14
D9284001040D9284001040W.H. Holden, Inc.EMO2026-01-14
00841013121050Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121067Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121074Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121128Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121135Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121142Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
00841013121159Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EMO2026-01-06
D9284005451HF0VESTIBULAR TUNNELING ELEVATOR #1 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005452HF0VESTIBULAR TUNNELING ELEVATOR #2 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005453HF0VESTIBULAR TUNNELING ELEVATOR #3 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005454HF0VESTIBULAR TUNNELING ELEVATOR #4 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005455HF0VESTIBULAR TUNNELING ELEVATOR #5 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
D9284005456HF0VESTIBULAR TUNNELING ELEVATOR #6 D/E HF HANDLEW.H. Holden, Inc.EMO2026-01-06
00840105223757ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223764ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223771ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223788ZOLL DENTALZoll-DentalEMO2025-08-06
00840105223795ZOLL DENTALZoll-DentalEMO2025-08-06
D928400531HFDLC0PA TUNNELING INSTRUMENT #2 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400532HFDLC0PA TUNNELING INSTRUMENT #3 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400533HFDLC0PA TUNNELING INSTRUMENT #4 D/E DLC HF HANDLEW.H. Holden, Inc.EMO2025-03-17
D928400110HF0PERIO KNIFE, TOWNER 19/20, HFW.H. Holden, Inc.EMO2025-02-06