FDA.reportPublic FDA data

ACTEON

Primary DI
03609820875743
Brand
ACTEON
Company
SATELEC
Model
PZ3 II
Catalog number
F87574
Device description
Intraoral bone surgery tip
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
03609820875743PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03609820875743036098208757433609820875743

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03609820875712ACTEONPZ1 IIF875712026-10-13
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
03609820877082ACTEON03.000.401SF877082019-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03609820875712ACTEONSATELECDZI2026-10-13
04560264508422VA-SG-SCNAKANISHI INC.DZI2026-10-05
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHDZI2026-06-23
07613327652703N/ASTRYKER CORPORATIONDZI2026-04-15
07613327652697N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652710PROstepSTRYKER CORPORATIONDZI2026-04-13
07613327652727N/ASTRYKER CORPORATIONDZI2026-04-13
07613327652734N/ASTRYKER CORPORATIONDZI2026-04-13
07613327654127TPXSTRYKER CORPORATIONDZI2026-04-13
04589551386758VA-SG-TIP HOLDERNAKANISHI INC.DZI2026-04-08
07613327652741N/ASTRYKER CORPORATIONDZI2026-03-25
07613327652758N/ASTRYKER CORPORATIONDZI2026-03-25
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHDZI2025-12-18
J021305020241Piezomed Pro AccessoryW & H Dentalwerk Bürmoos GmbHDZI2025-07-08
J021079971101"Instrument Set ""Implant/Crestal P"""W & H Dentalwerk Bürmoos GmbHDZI2023-04-04
J021077856001Instrument Z25PW & H Dentalwerk Bürmoos GmbHDZI2023-04-04
J021300320031WS-75 LGW & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300530021S-9W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300560021S-11W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300590011S-10W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300600011S-15W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300610011S-12W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
J021300650021WS-75W & H Dentalwerk Bürmoos GmbHDZI2022-06-23
ENOU1706A9Tubing setNouvag AGDZI2021-04-19
ENOU1706B9Tubing setNouvag AGDZI2021-04-19