FDA.reportPublic FDA data

Cavitron® DualSelect™

Primary DI
D003805281
Brand
Cavitron® DualSelect™
Company
Dentsply Professional
Model
80528
Catalog number
80528
Device description
Cavitron® DualSelect™ Dispensing System (G118)
Published
2022-11-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KYXDISPENSER, LIQUID MEDICATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYXDispenser, Liquid MedicationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D003805281PrimaryHIBCC0

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
144140845
Device count
1
Premarket exempt
true
Serial number
true

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Primary DI, Brand, Model table
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D0013035701Ceramco 33035703035702024-10-03
D0013036301Ceramco 33036303036302024-10-03
D0013038401Ceramco 33038403038402024-10-03
D0013039201Ceramco 33039203039202024-10-03
D0013050011Ceramco 33050013050012024-10-02
D0013050051Ceramco 33050053050052024-10-02
D0013050201Ceramco 33050203050202024-10-02
D0013050221Ceramco 33050223050222024-10-02
D0013051041Ceramco 33051043051042024-10-02
D0013051151Ceramco 33051153051152024-10-02
D0013051211Ceramco 33051213051212024-10-03
D0013051321Ceramco 33051323051322024-10-02
D0013051331Ceramco 33051333051332024-10-02
D0013051371Ceramco 33051373051372024-10-02

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