FDA.reportPublic FDA data

SONICflex cari-ex 1.4 No. 72

Primary DI
EKAV100073630
Brand
SONICflex cari-ex 1.4 No. 72
Company
KaVo Dental GmbH
Model
1.000.7363
Catalog number
cari ex 1 4 No 72
Device description
This is a medical device.This is a medical device.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
ELCScaler, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080089000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080089000SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPSSybron Dental Specialties, Inc.2008-09-04ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV100073630PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement systemAn assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-29 Degrees Celsius50 Degrees Celsius
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
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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