FDA.reportPublic FDA data

Cavitron®

Primary DI
D003813451
Brand
Cavitron®
Company
Dentsply Professional
Model
81345
Device description
Cavitron® Steri-Mate® Handpiece Sterile Lavage Adapter
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELCScaler, ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D003813451PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Oral lavage systemAn assembly of devices intended for automated or semi-automated irrigation and washing of tissue/debris from teeth, gums, and other parts of the oral cavity (e.g., tongue) through application of pulsed jets of non-medicated liquids (e.g., mouthwash, water), to maintain oral hygiene; it may in addition be intended for nasal lavage. It consists of a central mains electricity (AC-powered) unit with a reservoir and pump, and a number of hand-held applicators, each typically designed to clean a specific oral anatomy (e.g., tongue, braces, gum line). It is normally available [non-prescription] over-the-counter (OTC) for use in the home and dental office.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry, clean enviroment.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)989-8825xx@xx.xx

Regulatory Flags#

DUNS number
144140845
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0013032800Ceramco 33032803032802026-02-20
D0013031901Ceramco 33031903031902024-10-02
D0013032801Ceramco 33032803032802024-10-02
D0013034001Ceramco 33034003034002024-10-02
D0013034601Ceramco 33034603034602024-10-02
D0013035601Ceramco 33035603035602024-10-03
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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Primary DI, Brand, Company table
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07630392912648BioSonicDent4You AGELC2026-04-06
07613353352356GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-24
07613353313500GBT Machine StationE.M.S. Electro Medical Systems S.A.ELC2026-02-16
10889950154066PWR AirHU-FRIEDY MFG. CO., LLCELC2026-01-14
10889950154080HuFriedyGroupHU-FRIEDY MFG. CO., LLCELC2026-01-14
10889950154103HuFriedyGroupHU-FRIEDY MFG. CO., LLCELC2026-01-14
07613353335113PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-21
07613353341404PiezonE.M.S. Electro Medical Systems S.A.ELC2025-10-21
07613353257224AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353257323AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353257576AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-20
07613353258061AIR-FLOWE.M.S. Electro Medical Systems S.A.ELC2025-10-20
10810000520630Parkell®PARKELL, INC.ELC2023-10-20
10810000521552Parkell®PARKELL, INC.ELC2023-10-20
J021303230001Proxeo ULTRA PB-510W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303240001Proxeo ULTRA PB-520W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303250001Proxeo ULTRA PB-530W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303260001Proxeo ULTRA Handpiece PB-5 LW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303270001Proxeo ULTRA Handpiece PB-5 L QW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303280001Proxeo ULTRA Handpiece PB-5 L SW & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303530001MC-2.0 I (Motorcontroller Implantology)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303580001Perestaltic Pump W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303630001EXP-PD-ST-00 (Pump Controller)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303440001APP-HC-03-XX-00 (Head Controller)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303470001IFB-DC-CO.CO-HS-00 (Interface Board)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021303480001RFB-03-0200-00 (Rectifier-Board)W & H Dentalwerk Bürmoos GmbHELC2023-07-19
J021302780001MC-1.0 and AD-1.0 Analog MotorcontrollerW & H Dentalwerk Bürmoos GmbHELC2023-07-11