FDA.reportPublic FDA data

MECTRON

Primary DI
E322036300090
Brand
MECTRON
Company
MECTRON SPA
Model
MF1004L
Catalog number
03630009
Device description
MF1004L is a finishing surgical insert to be used in conjunction with Mectron Piezosurgery handpieces
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
JDXInstrument, Surgical, Sonic And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1
JDXInstrument, Surgical, Sonic And Accessory/AttachmentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153743000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153743000PIEZOSURGERY PLUSMectron S.P.A.2016-05-25JDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E322036300090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental ultrasonic surgical system handpiece tipA removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). It is used for implant site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty, and osteotomy. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
+16144594922info@piezosurgery.us

Regulatory Flags#

DUNS number
436664734
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E322036000220MECTRONMT1817L036000222026-04-20
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
E322048000061010MECTRONPD0118B -US-04800006-1012024-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-06-28
04589551366217P300-2A100NAKANISHI INC.ERL2026-06-26
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366217P300-2A100NAKANISHI INC.HWE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.ERL2026-06-26
04589551366262P300-2A120NAKANISHI INC.HWE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HWE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.ERL2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HWE2026-06-26
04589551366422PD-IN-2-120NAKANISHI INC.HWE2026-06-26
10886982237217NASYNTHES (U.S.A.) LPHWE2019-02-21
00821925011441DIEGOGyrus ACMI, LLCERL2017-05-11
10886982237613NASynthes GmbHHWE2017-02-20
10886982129512NASynthes GmbHHWE2016-12-31
10886982129598NASynthes GmbHHWE2016-12-31
10886982237729NASynthes GmbHHWE2016-12-31
10886982237989NASynthes GmbHHWE2016-12-31
10886982238795NASynthes GmbHHWE2016-12-31
10886982240323NASynthes GmbHHWE2016-12-31
10886982240347NASynthes GmbHHWE2016-12-31
10886982240361NASynthes GmbHHWE2016-12-31
10886982240385NASynthes GmbHHWE2016-12-31
00821925011410DIEGOGyrus ACMI, LLCERL2016-10-12
00821925028746DiegoGyrus ACMI, LLCERL2016-10-06
10886982064721NASynthes GmbHHWE2016-06-30
10886982064721NASynthes GmbHERL2016-06-30