FDA.reportPublic FDA data

Dentacenter Operative Dental Unit

Primary DI
D104SAF60646
Brand
Dentacenter Operative Dental Unit
Company
Safari Dentaire Inc
Model
SAF-606-4.6
Device description
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
Published
2023-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100212000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100212000DENTACENTER/EXPEDITION, MODEL SAF-430Safari Dental, Inc.2010-10-22EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D104SAF60646PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system instrument unit, electricA mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
245011531
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D104SAF4302Dentacenter Operative Dental UnitSAF-430-2SAF-430-22023-10-05
D104SAF1031Safari Dental ChairSAF-103-12023-10-02
D104SAF30201Dental Operating LightSAF-302-01SAF-302-012023-10-02
D104SAF430Dentacenter Operative Dental UnitSAF-4302023-10-02
D104SAF4302XP0Dentacenter Operative Dental UnitSAF-430-2XPSAF-430-2XP2023-10-02
D104SAF4303Dentacenter Operative Dental UnitSAF-430-22023-10-02
D104SAF433XP0Dentacenter Operative Dental UnitSAF-430-2XP2023-10-02
D104SAF470Dentacenter Operative Dental UnitSAF-4702023-10-02
D104SAF500CART0Dentacenter Operative Dental UnitSAF-500-CARTSAF-500-CART2023-10-02
D104SAF500M2Dentacenter Operative Dental UnitSAF-500-M22023-10-02
D104SAF500M4Dentacenter Operative Dental UnitSAF-500-M42023-10-02
D104SAF531SERIES2Dentacenter Operative Dental UnitSAF-531-Series II2023-10-02
D104SAF60626Dentacenter Operative Dental UnitSAF-606-2.62023-10-02

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Primary DI, Brand, Company table
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