FDA.reportPublic FDA data

INTRAmatic KL 703 LED

Primary DI
EKAV100701500
Brand
INTRAmatic KL 703 LED
Company
KaVo Dental GmbH
Model
1.007.0150
Catalog number
KL 703 LED
Device description
This is a medical device.
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKXHANDPIECE, DIRECT DRIVE, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKXHandpiece, Direct Drive, Ac-PoweredDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103027000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103027000ELECTROTORQUE TLCKaltenbach & Voigt GmbH2011-08-19EBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV100701500PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Remotely-driven dental drilling system motorA mains electricity (AC-powered) compact motor used in conjunction with a spinning cable (e.g., a Bowden cable) to provide remote rotational power from the motor to a dental drill handpiece. This device is line-powered and cannot be sterilized. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+18475506800customerservice@kavo.com

Regulatory Flags#

DUNS number
333710619
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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