FDA.reportPublic FDA data

CORONAflex 2005

Primary DI
EKAV057910000
Brand
CORONAflex 2005
Company
KaVo Dental GmbH
Model
0.579.1000
Catalog number
2005
Device description
This is a medical device.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
EISREMOVER, CROWN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EISRemover, CrownDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV057910000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental root elevatorA hand-held manual dental instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. 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
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

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