FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013105395
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEEXP6SEX
Device description
EXPLORER 6 SE 3/8
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
EIXPROBE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIXProbe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841013105395PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013105395008410131053958410131053950841013105395

GMDN Terms#

Term, Definition table
TermDefinition
Dental explorerA hand-held manual dental instrument designed for tactile examination (i.e., exploration) in the oral cavity, on the tooth surface and/or gums, mainly to find indentations (e.g., pits, fissures) for the determination of early tooth decay on the crown of teeth; it is also used in periodontology (e.g., to locate subgingival deposits before scaling). It is a long, slender instrument (a manual probe) with a stem that terminates in a thin working part at the distal end which may be needle-like, hooked, or blunt according to the intended use. 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
G149NPPEXP0NPSACME ENTERPRISE.EIX2026-05-01
00348783006438Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006629Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006766Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006780Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006803Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006810Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006827Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00348783006841Premier ProbesPREMIER DENTAL PRODUCTS COMPANYEIX2026-03-17
00840018674516Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-03-12
B382SD502210Surgical DirectSurgical Direct, Inc.EIX2026-02-26
00840018674097Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-11
00840018667051Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018667143Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018667792Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-10
00840018666498Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-09
00840018666597Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-02-09
B382SD12240Surgical DirectSurgical Direct, Inc.EIX2026-02-04
B382SD923898000Surgical DirectSurgical Direct, Inc.EIX2026-02-04
00840018662582Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-29
00840018663268Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-29
00840018661646Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIX2026-01-28
00841013120473Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EIX2026-01-06
D9284002151M0PERIO PROBE MARQUIS STYLE #1 CC 3-6-9-12W.H. Holden, Inc.EIX2026-01-06
00841336100985Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEIX2025-11-11
B382SD9252232010Surgical DirectSurgical Direct, Inc.EIX2025-09-18
B382SD49400Surgical DirectSurgical Direct, Inc.EIX2025-08-07
B382SD936091010Surgical DirectSurgical Direct, Inc.EIX2025-08-07
B382SD93770610810Surgical DirectSurgical Direct, Inc.EIX2025-08-07
B382SD9377061100Surgical DirectSurgical Direct, Inc.EIX2025-08-07