FDA.report

OSADA EXL-M40

Primary DI
04580406860478
Brand
OSADA EXL-M40
Company
OSADA ELECTRIC CO.,LTD.
Model
EXL-M40
Catalog number
3223
Published
2016-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EKXHANDPIECE, DIRECT DRIVE, AC-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04580406860478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04580406860478045804068604784580406860478

GMDN Terms

TermDefinition
Dental laboratory power tool systemAn assembly of devices intended to be used in a dental laboratory to bore/cut/grind dental fixtures, appliances, and materials for their preparation or repair. It typically consists of a drilling handpiece, a compact mains electricity (AC-powered) motor, an enclosed and flexible spinning cable (e.g., a Bowden cable), and a variety of dental power tool attachments to hold the active instruments (e.g., drills, burs, grind wheels). The spinning cable provides power to the handpiece from the electric motor which is placed distant from the site of operation, providing additional protection from exposure to electrical current. The system is typically combined with various speed controllers.

Sterilization Methods

Method

Regulatory Flags

DUNS number
690713813
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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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04580406860720AP set 7AP set 7507962016-09-20
04580406860737AP point 1AP point 1460442016-09-20
04580406860744AP point 2AP point 2460452016-09-20
04580406860751AP point 3AP point 3460462016-09-20
04580406860768Diamond file A2Diamond file A2460502016-09-20
04580406860775Diamond file A3Diamond file A3460512016-09-20
04580406860782Diamond file L1Diamond file L1460472016-09-20
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04582227379856SC point 4-19SC point 4-19500772016-09-20
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04582227397089Plugger set#20Plugger set#20819132016-09-20
04582227397096Plugger set#30Plugger set#30819252016-09-20

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