FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013104992
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEEXC42-43
Device description
EXCAVATOR 42-43 (15-8-14)
Published
2022-07-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKCExcavator, Dental, Operative
EMOKNIFE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1
EMOKnife, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841013104992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013104992008410131049928410131049920841013104992

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
Dry Heat Sterilization

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
00841013124648MicroquoreAESNHMACS2026-06-26
00841013124655MicroquoreAESNHBAC2026-06-26
00841013124686MicroquoreAESMSNH2026-06-26
00841013124693MicroquoreAESMSSTT2026-06-26
00841013124709MicroquoreAESMSTCO2026-06-26
00841013124716MicroquoreAESMSSSM2026-06-26
00841013124723MicroquoreAESMSSTD2026-06-26
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00348783008685Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008692Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
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00348783008715Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
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