FDA.report

American Eagle Instruments

Primary DI
00841013104671
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEED11T-25S
Device description
SPREADER D11T-25
Published
2022-07-12
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
false

Related Records

Product Codes

CodeName
EKKSPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EKKSpreader, Pulp Canal Filling Material, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841013104671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013104671008410131046718410131046710841013104671

GMDN Terms

TermDefinition
Manual endodontic filling material spreaderA hand-held, manually-operated dental instrument specifically designed to compress filling materials in a root canal, mainly in a lateral direction. The working part is tapered, circular in cross-section and has a pointed tip. This is a reusable device.

Sterilization Methods

Method
Dry Heat Sterilization

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
true

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00348783009477Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-03-17
00348783009491Premier SpreaderPREMIER DENTAL PRODUCTS COMPANYEKK2026-03-17
00840456213513JMUJMU DENTAL, INCEKK2025-08-18
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
00889813066843Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2024-11-30
00889813066850Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKK2024-11-30
08800075609809OSUNG MNDOSUNG MND Co., Ltd.EKK2024-03-04
08800075624048OSUNG MNDOSUNG MND Co., Ltd.EKK2024-03-04
06975718055359Denco SHENZHEN DENCO MEDICAL CO., LTDEKK2023-12-27
06975718055366Denco SHENZHEN DENCO MEDICAL CO., LTDEKK2023-12-27
06975718055373Denco SHENZHEN DENCO MEDICAL CO., LTDEKK2023-12-27
06975718055380Denco SHENZHEN DENCO MEDICAL CO., LTDEKK2023-12-27
D6919053814Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053816Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053818Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053820Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053826Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053830Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053832Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053834Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053836Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
D6919053842Premier SPREADERSPREMIER DENTAL PRODUCTS COMPANYEKK2023-10-17
E226006824A38KOMET SpreaderGebr. Brasseler GmbH & Co. KGEKK2023-08-25
E226006825A38KOMET SpreaderGebr. Brasseler GmbH & Co. KGEKK2023-08-25
E226006826A38KOMET SpreaderGebr. Brasseler GmbH & Co. KGEKK2023-08-25
E226006827A38KOMET SpreaderGebr. Brasseler GmbH & Co. KGEKK2023-08-25
E226006828A38KOMET SpreaderGebr. Brasseler GmbH & Co. KGEKK2023-08-25
E226006829A38KOMET SpreaderGebr. Brasseler GmbH & Co. KGEKK2023-08-25