FDA.reportPublic FDA data

MECTRON

Primary DI
E322029001090010
Brand
MECTRON
Company
MECTRON SPA
Model
K8
Catalog number
02900109-001
Device description
K8 is a torque wrench used for tightening inserts to the Mectron ultrasonic handpieces.
Published
2016-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151248000PIEZOSURGERY WHITEMectron S.P.A.2015-09-04DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E322029001090010PrimaryHIBCC0

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
Lot or batch
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613353194963PIEZON Handpiece S5E.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353240950PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353257743AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353311803Instrument PI starter kitE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318123GBT Machine Wireless PedalE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318581AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353334833GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353343408PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353028374PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170318PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170325PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353223182PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353225117PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
04560264548459Powder Handpiece(For Prophy use)NAKANISHI INC.ELC2026-06-11
04560264548473Powder Handpiece(For Perio use)NAKANISHI INC.ELC2026-06-11
04560264579538CLM Bottole SetNAKANISHI INC.ELC2026-06-11
04560264579569CLM HolderNAKANISHI INC.ELC2026-06-11
04589551391202Prophy Kit2NAKANISHI INC.ELC2026-06-11