FDA.report

SiroCam F

Primary DI
E27664157770
Brand
SiroCam F
Company
SIRONA Dental Systems GmbH
Model
6415777
Device description
SiroCam F
Published
2016-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBWController, Foot, Handpiece And Cord

Product Code Classifications

CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E27664157770PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
+4962511670contact@dentsplysirona.com

Regulatory Flags

DUNS number
340306351
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10194665008499A-decA-DEC, INC.EBW2026-02-19
10194665008505A-decA-DEC, INC.EBW2026-02-19
10194665008512A-decA-DEC, INC.EBW2026-02-19
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