FDA.reportPublic FDA data

Silfradent S.r.l.

Primary DI
08056093310016
Brand
Silfradent S.r.l.
Company
SILFRADENT SRL
Model
SURGYBONE na
Device description
SURGYBONE, the electromedical equipment by SILFRADENT Srl, is a dental instrument performing operations in the field of dental piosthesis and endodontics by means of ultrasound vibrations produced by a piezoelectric transducer.
Published
2016-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083569000SURGYBONESilfradent S.R.L.2009-04-01DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18056093310013PackageGS11In Commercial Distribution
08056093310016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805609331001318056093310013
08056093310016080560933100168056093310016

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement systemAn assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Regulatory Flags#

DUNS number
439064973
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056093310023SILFRADENT srlSB P01002017-03-01
08056093310030SILFRADENT srlSB P02002017-03-01
08056093310047SILFRADENT srlSB P03012017-03-01
08056093310054SILFRADENT srlSB P03102017-03-01
08056093310061SILFRADENT srlSB P03212017-03-01
08056093310078SILFRADENT srlSB P04002017-03-01
08056093310085SILFRADENT srlSB P05002017-03-01
08056093310092SILFRADENT srlSB P06002017-03-01
08056093310108SILFRADENT srlSB P06102017-03-01
08056093310115SILFRADENT srlSB P07002017-03-01
08056093310122SILFRADENT srlSB P07102017-03-01
08056093310139SILFRADENT srlSB P07202017-03-01
08056093310146SILFRADENT srlSB P07502017-03-01
08056093310153SILFRADENT srlSB P08002017-03-01
08056093310160SILFRADENT srlSB P08052017-03-01
08056093310177SILFRADENT srlSB P08102017-03-01
08056093310184SILFRADENT srlSB P08302017-03-01
08056093310191SILFRADENT srlSB P09002017-03-01
08056093310207SILFRADENT srlSB P09102017-03-01
08056093310214SILFRADENT srlSB P09202017-03-01

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