FDA.reportPublic FDA data

Extension set ultrasonic for EndoPilot

Primary DI
04260482990824
Brand
Extension set ultrasonic for EndoPilot
Company
Schlumbohm GmbH & Co. KG
Model
v01
Catalog number
110 3002
Device description
Extension set ultrasonic for EndoPilot²:consisting of:Ultrasonic module,Ultrasonic handpiece Newtron/ Satelec,Ultrasonic handpiece cable, Satelec, (aprox. 180cm),Rinsing adapter,Universal wrench,and a half base plate.
Published
2022-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202906000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202906000EndoPilot2Schlumbohm GmbH & Co. KG2021-04-13ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260482990824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260482990824042604829908244260482990824

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
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""High-level Disinfectant""]"
Moist Heat or Steam Sterilization;High-level Disinfectant

Regulatory Flags#

DUNS number
343831731
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
04260482991227CanalPro Jeni Setv07600429282026-05-20
04260482991166EndoPilot D-Pack² handpiecev04109 0151-042025-01-28
04260482991173EndoPilot² expansion DownPack²v01110 0132-US-v012025-01-28
04260482991128EndoPilot Obtura setv01110 0133-US2021-10-14
04260482990190EndoPilot D-Packv03109 01512021-09-10
04260482991135EndoPilot DownPack expansion setv00110 0132-US2021-09-10
04260482990084EndoPilot MotorEDP2109 01122021-06-02
04260482990602EndoPIlot wireless-footswitch, singlebluetooth109 23612021-06-02
04260482990763EndoPilot Control Box, KometEDP2110 20112021-06-02
04260482990787EndoPilot power supplyUS110 22032021-06-02
04260482990817EndoPilot retainer for apexcableEDP2110 23032021-06-02
04260482990923EndoPilot Cap for lip-contactEDP2109 23182021-06-02
04260482990282EndoPilot apex cable setEDP2109 23112021-05-31
04260482990305EndoPilot Lip-clipEDP2109 23142021-05-31
04260482990589EndoPilot Apex measuring cable with plugEDP2109 23122021-05-31
04260482990596EndoPilot wireless-footswitch, twinbluetooth109 23512021-05-31
04260482990893EndoPilot cable for file clampEDP2109 23152021-05-31
04260482990916EndoPilot File clampEDP2109 23162021-05-31
04260482990091EndoPilot contra-angle1:1109 01262021-05-25
04260482991029EndoPilot Kometcomfort110 06072021-05-25

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