FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013108358
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEHA17-18
Published
2022-05-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841013108358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013108358008410131083588410131083580841013108358

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.

Regulatory Flags#

DUNS number
790776850
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841013120435American Eagle Instruments, Inc.AEFH3-7XPZAEFH3-7XPZ2025-02-18
00841013120442American Eagle Instruments, Inc.AEFH5-11XPZAEFH5-11XPZ2025-02-18
00841013101892American Eagle InstrumentsAEB2-30BEFAEB2-30BEF2022-07-24
00841013102059American Eagle InstrumentsAEBM1TNAEBM1TN2022-07-24
00841013109607American Eagle InstrumentsAEPBP-2AEPBP-22022-07-24
00841013101878American Eagle InstrumentsAEB21BAAEB21BA2022-05-23
00841013101908American Eagle InstrumentsAEB26-27BAEB26-27B2022-05-23
00841013101915American Eagle InstrumentsAEB26-28BFAEB26-28BF2022-05-23
00841013101922American Eagle InstrumentsAEB26-29BFAEB26-29BF2022-05-23
00841013101939American Eagle InstrumentsAEB26-30BFAEB26-30BF2022-05-23
00841013101946American Eagle InstrumentsAEB26-30BFTNAEB26-30BFTN2022-05-23
00841013101953American Eagle InstrumentsAEB26-30BFTNZAEB26-30BFTNZ2022-05-23
00841013102004American Eagle InstrumentsAEBH6AEBH62022-05-23
00841013102011American Eagle InstrumentsAEBH7AEBH72022-05-23
00841013102066American Eagle InstrumentsAEBM1TNZAEBM1TNZ2022-05-23
00841013102073American Eagle InstrumentsAEBNYUB-1AEBNYUB-12022-05-23
00841013102080American Eagle InstrumentsAEBPFI18BAEBPFI18B2022-05-23
00841013102097American Eagle InstrumentsAEBPFI21AAEBPFI21A2022-05-23
00841013102103American Eagle InstrumentsAEBPP18AEBPP182022-05-23
00841013108600American Eagle InstrumentsAEMCB21ATNZ2022-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454001530COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001547COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001554COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001608COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001622COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001639COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001646COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001660COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454001677COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002216COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002667COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454002674COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454004203COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454004210COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454007310COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010815COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010822COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010839COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454010846COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454011584COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454011744COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012086COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012949COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454012956COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454013137COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454014516COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015896COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015902COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015919COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26
06954454015926COTISENHuanghua Promisee Dental Co., Ltd.EIY2026-10-26