FDA.reportPublic FDA data

INTEGO pro TS ambidextrous with disinfection

Primary DI
E27665918580
Brand
INTEGO pro TS ambidextrous with disinfection
Company
SIRONA Dental Systems GmbH
Model
6591858
Device description
Treatment Center INTEGO pro TS ambidextrous with disinfection
Published
2016-09-10
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
EBWController, Foot, Handpiece And Cord
EIAUnit, Operative Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1
EIAUnit, Operative DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150909000INTEGO Family and AccesoriesSirona Dental Systems GmbH2015-07-17EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E27665918580PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery systemA stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4962511670contact@dentsplysirona.com

Regulatory Flags#

DUNS number
340306351
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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E27668303060Midwest Power Lux Motor683030668303062026-02-13
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E27668082030Primescan 268082032025-11-21
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E27668082450Primescan 2680824568082452025-10-23
E27668534800CAD/CAM Software68534802025-08-19
E27660471250Motor BL 60471252016-09-10
E27663375180Motor BL ISO C63375182016-09-10
E27663082950TiBase63 08 29563 08 2952015-10-17
E27668665240Midwest68665242025-10-17
E27668053651Primescan 2 Multiuse Sleeve680536568053652025-09-16
E27668558402Primescan 2685584068558402025-08-20
E27668020400Primescan 2680204068020402025-05-16
E27665716860SiroLaser65716862025-09-03

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