FDA.report

American Eagle Instruments

Primary DI
00841013101885
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEB2-29BEF
Published
2022-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EKJBurnisher, Operative
EKKSPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1
EKKSpreader, Pulp Canal Filling Material, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841013101885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013101885008410131018858410131018850841013101885

GMDN Terms

TermDefinition
Manual dental burnisher, reusableA hand-held manual dental device with a smooth or ribbed working head intended to be used to create thin margins between a dental restoration and the enamel at the cavo-surface angle, and/or to polish the surface of metallic restorations by rubbing. Its terminus is round or ball-shaped and is typically made of metal. This is a reusable device.

Sterilization Methods

Method

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

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00841013120497Otto LeibingerAESPPR3S2026-01-06
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00841013120534Otto LeibingerAESPWI062026-01-06
00841013120541Otto LeibingerAESPBU2026-01-06
00841013120558Otto LeibingerAESPM92026-01-06
00841013120565Otto LeibingerAESPM2026-01-06
00841013120572Otto LeibingerAESBS12026-01-06
00841013120589Otto LeibingerAESBS22026-01-06
00841013120596Otto LeibingerAESRCBA2026-01-06
00841013120602Otto LeibingerAESSCLU222026-01-06
00841013120619Otto LeibingerAESSCLU332026-01-06
00841013120626Otto LeibingerAESSCLU112026-01-06
00841013120633Otto LeibingerAESRCW2026-01-06
00841013120640Otto LeibingerAESRLAN12026-01-06

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00348783009361Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-03-17
00348783009477Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-03-17
00348783009491Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-03-17
00840018667389Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018671508Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018672314Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018665729Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-09
00840018666139Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-09
00840018662247Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-01-29
00840018662896Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-01-29
00840456213513JMUJMU DENTAL, INCEKK2025-08-18
05010058178090InstrapacROBINSON HEALTHCARE LIMITEDEKJ2025-06-23
00889813066867Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2025-03-12
00841013120435American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKK2025-02-18
00841013120442American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKK2025-02-18
00889813065884Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065891Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065907Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065914Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065921Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065945Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813066157Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813066843Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2024-11-30
00889813066850Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2024-11-30
00889813065938Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-10-01
00813677025159PDT, Inc.PDT, INC.EKJ2024-09-11
00813677025166PDT, Inc.PDT, INC.EKJ2024-09-11
00842517118652Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
00842517118669Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
00842517118676Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06