FDA.reportPublic FDA data

ACTEON

Primary DI
03609820873114
Brand
ACTEON
Company
SATELEC
Model
TIP SL1
Catalog number
F87311
Device description
Diamond-coated tip for vestibular bone window cut and for attenuation of sharp angles
Published
2016-09-24
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091252000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091252000IMPLANT CENTER 2Satelec2009-07-22DZI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03609820873114PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03609820873114036098208731143609820873114

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+33556340607info@acteongroup.com

Regulatory Flags#

DUNS number
381582196
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
03609820877082ACTEON03.000.401SF877082019-12-23
03609820877099ACTEON03.000.402SF877092019-12-23
03609820877112ACTEON03.000.409SF877112019-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327652703N/ASTRYKER CORPORATIONDZI2026-04-15
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07613327652734N/ASTRYKER CORPORATIONDZI2026-04-13
07613327654127TPXSTRYKER CORPORATIONDZI2026-04-13
07613327652741N/ASTRYKER CORPORATIONDZI2026-03-25
07613327652758N/ASTRYKER CORPORATIONDZI2026-03-25
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHDZI2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHDZI2025-12-18
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J021305030121Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030131Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030141Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030151Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
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J021305030171Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030181Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22
J021305030191Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-09-22