FDA.reportPublic FDA data

MECTRON

Primary DI
E322029001370010
Brand
MECTRON
Company
MECTRON SPA
Model
K10
Catalog number
02900137-001
Device description
K10 is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces.
Published
2019-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140965000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140965000MULTIPIEZO PRO, MULTIPIEZOMectron S.P.A.2014-08-20ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E32202900137Direct MarkingHIBCC0
E322029001370010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic surgical system torque wrench, reusableA hand-held instrument designed to manually attach or detach a handpiece tip (blade) from the handpiece of an ultrasonic surgical system. It is typically formed with a socket that is placed over the handpiece tip and rotated by the operator to tighten or loosen, with appropriate torque, the tip to or from the handpiece. The device is made of durable materials and typically includes a mechanism to prevent under- or over-tightening. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 6144594922info@piezosurgery.us

Regulatory Flags#

DUNS number
436664734
Device count
1
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E322036000220MECTRONMT1817L036000222026-04-20
E322036300090MECTRONMF1004L036300092026-04-20
E322033800150MECTRONOP1125033800152026-02-18
E322033800160MECTRONOP1225033800162026-02-18
E322034000110MECTRONEX0410034000112026-02-18
E322034000120MECTRONEX0510034000122026-02-18
E322034000130MECTRONEX0610034000132026-02-18
E322048000111010MECTRONPD0620A -US-04800011-1012026-02-18
E322048000121010MECTRONPD0620B -US-04800012-1012026-02-18
E322051000851010MECTRONstarlight pro - SHINY YELLOW -USA05100085-1012025-06-17
E322051000861010MECTRONstarlight pro - MATT BLACK -USA05100086-1012025-06-17
E322051000871010MECTRONstarlight pro - SHINY SILVER -USA05100087-1012025-06-17
E322031202490010MECTRONMANIPOLO PIEZOSURGERY® medical +03120249-0012025-06-16
E322036300080MECTRONMF0804+036300082025-06-16
E322051000831010MECTRONstarlight pro - SHINY WHITE -USA05100083-1012025-06-16
E322048000011010MECTRONPD0118A -US-04800001-1012024-10-15
E322048000021010MECTRONPD0223A -US-04800002-1012024-10-15
E322048000031010MECTRONPD0328A -US-04800003-1012024-10-15
E322048000041010MECTRONPD0432A -US-04800004-1012024-10-15
E322048000051010MECTRONPD0535A -US-04800005-1012024-10-15

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Primary DI, Brand, Company table
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