FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013104510
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEDGMAXPX
Device description
DBL GRACEY MINI ANTERIOR XPX GREEN
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
EMSCURETTE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMSCurette, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841013104510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013104510008410131045108410131045100841013104510

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. 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
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
00348783007466Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007473Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007534Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007541Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007558Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007565Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007572Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007596Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007602Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007619Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007671Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783007756Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008159Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008166Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008173Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008197Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008210Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008227Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008234Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008241Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00348783008258Premier CurettesPREMIER DENTAL PRODUCTS COMPANYEMS2026-03-17
00840018674547Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674554Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674561Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-14
00840018674493Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-12
00840018674509Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-12
04251436943843KOHLERKohler Medizintechnik GmbHEMS2026-03-12
00840018674295Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11
00840018674301Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11
00840018674318Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMS2026-03-11