FDA.report

American Eagle Instruments

Primary DI
00841013103186
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AECAWO1
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
EKHCARVER, DENTAL AMALGAM, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKHCarver, Dental Amalgam, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841013103186PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013103186008410131031868410131031860841013103186

GMDN Terms

TermDefinition
Dental restoration carver, amalgam, reusableA hand-held manual dental instrument intended to be used for producing and perfecting anatomical forms in dental amalgam restorations, typically by cutting, scraping, paring, and smoothing finishes and modelling patterns intraorally. It will typically be a double-ended instrument with working ends of various shapes and designs, and a central handle. 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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00841013120640Otto LeibingerAESRLAN12026-01-06

Other Devices Sharing Product Codes

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00840018674141Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKH2026-02-11
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05010058180185InstrapacROBINSON HEALTHCARE LIMITEDEKH2025-06-23
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00842517118690Karl SchumacherKarl Schumacher Dental, LLCEKH2024-05-06
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