FDA.reportPublic FDA data

SIROPREP

Primary DI
E27659473580
Brand
SIROPREP
Company
SIRONA Dental Systems GmbH
Model
5947358
Device description
SIROPREP M 2
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
E27659473580PrimaryHIBCC0

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
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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E27668302980Midwest Power Lux Implant Motor683029868302982026-02-13
E27668303060Midwest Power Lux Motor683030668303062026-02-13
E27665716860SiroLaser65716862025-09-03
E27662122080Motor BL implant62122082025-08-20
E27668534800CAD/CAM Software68534802025-08-19
E2766802040Primescan 2680204068020402025-05-16
E27668020400Primescan 2680204068020402025-05-16
E27668053650Primescan 2 Multiuse Sleeve680536568053652025-05-06
E27668325750TiBase683257568325752025-05-06
E27668325830TiBase683258368325832025-05-06
E27668326090TiBase683260968326092025-05-06
E27668326170TiBase683261768326172025-05-06
E27668326250TiBase683262568326252025-05-06
E27668326330TiBase683263368326332025-05-06
E27668326580TiBase683265868326582025-05-06
E27668326660TiBase683266668326662025-05-06
E27668004570Primescan 2 Cart680045768004572025-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126506238Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506245Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506252Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506269Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506276Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506283Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506290Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506306Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506313Dream by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
00810126506320Dream By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCELC2026-03-05
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04589551387168Tip Cover LNAKANISHI INC.ELC2026-01-21
04589551387151Tip Cover SNAKANISHI INC.ELC2026-01-21
04589551382828E TIP WRENCHNAKANISHI INC.ELC2026-01-21
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045895513889743 Mode Select SwitchNAKANISHI INC.ELC2026-01-21