FDA.reportPublic FDA data

SIROSONIC

Primary DI
E27659135090
Brand
SIROSONIC
Company
SIRONA Dental Systems GmbH
Model
5913509
Device description
SIROSONIC L
Published
2016-09-16
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
EIAUnit, Operative Dental
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIAUnit, Operative DentalDental1
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K033640000
K150909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K033640000SIROSON L AND SIROSONIC L ULTRASONIC SCALERSSirona Dental Systems GmbH2003-12-12ELC
K150909000INTEGO Family and AccesoriesSirona Dental Systems GmbH2015-07-17EIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E27659135090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, periodontalAn insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
340306351
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E27668907712Single use sleeve Primescan Box68907712026-09-22
E27667732580Sidexis 467732582022-12-20
E27667737871Sidexis 467737872022-12-20
E27667755841Sidexis 467755842022-12-20
E27667755921Sidexis 467755922022-12-20
E27666182630Sidexis 466182632021-12-23
E27662291290SIDEXIS XG62291292016-09-10
E27664565320SIDEXIS 464565322016-09-10
E27666164650Sidexis 466164652017-04-20
E27666632770Sidexis 466632772018-08-27
E27668234260Primevision 3D682342667585982026-02-13
E27668234830Primevision 3D68234832026-04-30
E27668665320Midwest IMPLANT 20:168665322026-02-19
E27668312130Midwest Motor Control Module683121368312132026-02-17
E27668302980Midwest Power Lux Implant Motor683029868302982026-02-13
E27668303060Midwest Power Lux Motor683030668303062026-02-13
E27660437020IMPLANT 20:160437022016-09-10
E27668082030Primescan 268082032025-11-21
E27668325910TiBase683259168325912025-10-28
E27668326410TiBase683264168326412025-10-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06975659690114YADENGGuangdong Yadeng Medical Apparatus CO .,LTDEIA2026-10-07
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