FDA.reportPublic FDA data

ACTEON

Primary DI
03609820877099
Brand
ACTEON
Company
SATELEC
Model
03.000.402S
Catalog number
F87709
Device description
Long, ultra-sharp saw (15mm), slim profile, equipped with four sharpened teeth, intended for facilitating ramus grafts.Alternative DI : 10887587009698
Published
2019-12-23
Public version status
Update
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
JDXInstrument, Surgical, Sonic And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDXInstrument, Surgical, Sonic And Accessory/AttachmentOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100410000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100410000PIEZOELECTRIC SYSTEMSatelec2010-04-28JDX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03609820877099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03609820877099036098208770993609820877099

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3556340607info@acteongroup.com

Regulatory Flags#

DUNS number
381582196
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03609820875712ACTEONPZ1 IIF875712026-10-13
03609820875743ACTEONPZ3 IIF875742026-10-13
03609820244846ACTEONCOCOON VET. SPRAY 115VF244842019-12-24
03609820876948ACTEONRHL2F876942025-12-12
03609820101286BUSE PERIO MAINT AIR N GO EASYF10128 F10128 2025-12-10
03609820555423SP NEWTRON LED 4K3.7V US EMB F55542F555422025-12-10
03609820876849ACTEONRHL5 M+F876842025-08-04
03609820876917ACTEONRHL4R M+F876912025-08-04
03609820876924ACTEONRHL4L M+F876922025-08-04
03609820876931ACTEONRHL6 M+F876932025-08-04
03609820128184ACTEON05.001.401F128182025-01-17
03609820577104ACTEON05.001.400F577102025-01-17
03609820599359ACTEON03.000.400.05SF599352025-01-17
03609820599366ACTEON03.000.400.01SF599362025-01-17
03609820877334ACTEON03.000.424SF877332025-01-17
03609820877020ACTEON03.000.403SF877022019-12-23
03609820877037ACTEON03.000.404SF877032019-12-23
03609820877044ACTEON03.000.405SF877042019-12-23
03609820877068ACTEON03.000.406SF877062019-12-23
03609820877075ACTEON03.000.407SF877072019-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972603519682SMTPSMTP Medical Co., Ltd.JDX2026-06-08
E322036000220MECTRONMECTRON SPAJDX2026-04-20
E322036300090MECTRONMECTRON SPAJDX2026-04-20
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J021305030031Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030041Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030051Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030061Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030071Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
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J021305030141Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
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J021305030191Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030201Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030211Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030221Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030231Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305030241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHJDX2025-09-22
J021305000001Piezomed Pro M-PM100W & H Dentalwerk Bürmoos GmbHJDX2025-07-08
J021305010001Piezomed Pro M-PH350W & H Dentalwerk Bürmoos GmbHJDX2025-07-08