FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013108600
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEMCB21ATNZ
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
EKJBurnisher, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841013108600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013108600008410131086008410131086000841013108600

GMDN Terms#

Term, Definition table
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.

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
00841013109768American Eagle InstrumentsAEPPA2022-05-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD28020Surgical DirectSurgical Direct, Inc.EKJ2026-07-31
00850083275655Intrace USAPILOTIS TECH LLCEKJ2026-07-03
00348783009378Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783009385Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
00348783009392Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-04-01
10889950147372Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147389Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147716Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147747Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147754Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147761Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147792Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147884Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950147914Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148065Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
10889950148102Hu-FriedyHU-FRIEDY MFG. CO., LLCEKJ2026-02-24
00841013120435American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKJ2025-02-18
00841013120442American Eagle Instruments, Inc.AMERICAN EAGLE INSTRUMENTS, INC.EKJ2025-02-18
07898506811656QuinelatoSchobell Industrial LtdaEKJ2022-12-08
07898506843459QuinelatoSchobell Industrial LtdaEKJ2022-12-08
00841013101892American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-07-24
00841013102059American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-07-24
00841013109607American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-07-24
00841013101878American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101908American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101915American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101922American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101939American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101946American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23
00841013101953American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EKJ2022-05-23