SATELEC-ACTEON GROUP

FDA Device Registration & Listing · MERIGNAC Gironde, FR · Registration 8044015

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8044015
FEI Number
3004536551
Entity Name
SATELEC-ACTEON GROUP
City/State/Country
MERIGNAC Gironde, FR
Establishment Address
Z.I. DU PHARE, 17, AVENUE GUSTAVE EIFFEL, MERIGNAC Gironde 33708, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
SATELEC-ACTEON GROUP (Owner Number: 9004992)
Owner / Operator Contact Address
1001 Briggs Rd, Suite 220, Mount Laurel, NJ 08054, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

NEWTRON P5 B.LED NEWTRON P5 Drill, Bone, Powered PIEZOTOME SOLO PIEZOTOME SOLO LED Otoscope Device Electrical Dental Anesthesia Scaler Ultrasonic Unit Operative Dental EVOS Dental Hand-Piece and Accessories ENDO Dual i-endo dual dental motor, endo motion Scaler Ultrasonic Scaler Ultrasonic PIEZOTOME CUBE Scaler Ultrasonic PIEZOTOME Drill, Bone , Powered MINI-LED AF OEM MINI-LED AF Newtron P5 XS B.LED Satelec Newtron P5 XS B.LED Satelec Newtron P5 XS Satelec Newtron P5 XS / P5 XS B.LED Newtron P5 XS EDGETIP - #1, #2, #3, #4, #5, #6, #7, #8 Endo Tips - ETBD, ET18D, ET20D, ET40D, ET25S, ET25, ET25L EDGESURGICALTIP - #1, #2, #3, #4, #5, #6 Surgical Tips - AS3D, P15LD, ASLD, P15RD, ASRD Air-N-Go by Satelec Air-N-Go Easy by Satelec handpiece Air Powered Dental Unit Operative Dental Scanwave Pen OEM NWT CAN SLIM LED CORD G3 SHORT SP NEWTRON CAN A NWT CAN SLIM LED CORD G3 LONG MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; Unit Electrosurgical and Accessories Dental Scaler Ultrasonic SMARTLITE Mini L.E.D. , Celalux 2 Mini-Led Black MINI-LED SUPER CHARGEED MINI-L.E.D. SP MINI-L.E.D. ORTHRO 2 MINI L.E.D. OEM MINI-LED BLUE RAY 2 MINI-L.E.D. REGULAR MINI LED BLUE RAY 3 IMPLANT CENTER 2 Implant Center 2 with I-Surge LED motor Drill, bONE, pOWERED Handpiece Air Powered Dental ProUltra Piezo Ultrasonic Satelec ProUltra Piezo Ultrasonic Scaler Ultrasonic PIEZOTOME M+ Bone Surgery Tips PIEZOTOME M+ Bone Surgery Tips: RHS1, RHS2Fb, RHS2Hb, RHS3L, RHS3R, RHS4L, RHS4R, RHS5, RHL5, RHS6 NINJA M+ N STER CE2 M+ N STER INSERT BS1 RD M+ N STER INSERT SL2 M+ N STER INSERT BS2L XL M+ N STER SL4 M+ N STER INSERT BS1 XXL M+ N STER BS5 M+ N STER PIEZOTOME SOLO M+ US LC1 XL M+ N STER SL5 M+ N STER KIT RHS EXPERT M+ N STER LC1 M+ N STER INSERT BS2R XL M+ N STER CS6 M+ N STER INSERT BS6 XXL M+ N STER TKW5 M+ N STER INSERT SL3 M+ N STER KIT CMF NON STERILE TIP RHS3L M+ N STER INSERT SL1 M+ N STER TKW4 M+ N STER CS4 M+ N STER LC2 M+ N STER INSERT BS4 M+ N STER INSERT RHS4L N STER TKW2 M+ N STER CE3 M+ N STER INSERT RHS2Fb N STER CS1 M+ N STER BS1S M+ N STER INSERT RHS2Hb N STER TKW1 M+ N STER TIP RHS5 M+ N STER CS2 M+ N STER TKW3 M+ N STER DB 2 M+ N STER CS3 M+ N STER CE1 M+ N STER TIP RHS6 M+ N STER TIP RHS3R M+ N STER BS2R M+ N STER INSERT RHS4R N STER KIT RHS BASIC M+ N STER BS6 M+ N STER INSERT BS1L M+ N STER LC2R M+ N STER BS2L M+ N STER INSERT RHS1 N STER LC2L M+ N STER CS5 M+ N STER DB 1 M+ N STER RHL4R M+ RHL5 M+ RHL6 M+ RHL2 RHL4L M+ FLAG FOR B.LED SATELEC FLAG FOR B.LED Activator Ultraviolet for Polymerization Newtron Booster Ultrasonic Scaler MINI L.E.D SUPERCHARGED O.E.M ULTRAWAVE xs ULTRAWAVE P5 Newtron XS Scaler Ultrasonic Scaler Ultrasonic

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2014-03-13
DZI Drill, Bone, Powered Dental Class 2 872.4120 2007-12-10
DZI Drill, Bone, Powered Dental Class 2 872.4120 2012-02-13
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 1995-08-02
LWM Device, Electrical Dental Anesthesia Unknown Class U N/A 2008-02-15
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2007-12-10
EIA Unit, Operative Dental Dental Class 1 872.6640 2008-02-15
EBW Controller, Foot, Handpiece And Cord Dental Class 1 872.4200 2014-11-25
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2008-02-15
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2007-12-10
DZI Drill, Bone, Powered Dental Class 2 872.4120 2018-05-03
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2008-02-15
DZI Drill, Bone, Powered Dental Class 2 872.4120 2006-05-16
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2007-12-10
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2014-03-21
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2011-12-13
EIA Unit, Operative Dental Dental Class 1 872.6640 2008-02-15
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2014-04-17
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2025-04-09
EKZ Unit, Electrosurgical, And Accessories, Dental Dental Class 2 872.4920 2008-02-15
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2008-02-15
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2008-02-15
DZI Drill, Bone, Powered Dental Class 2 872.4120 2009-07-23
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2007-12-10
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2012-02-27
JDX Instrument, Surgical, Sonic And Accessory/Attachment Orthopedic Class 2 888.4580 2017-10-20
NYH Plaque Disclosing Kit Dental Class 2 872.1740 2015-05-15
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2008-02-15
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2013-12-03
EBZ Activator, Ultraviolet, For Polymerization Dental Class 2 872.6070 2008-02-15
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2007-12-10
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2008-02-15

Official Correspondent

Noelle Zuccarello

US Agent Details

Noelle Zuccarello Business: Acteon, Inc Email: noelle.zuccarello@acteongroup.com Phone: (800) 2896367

Related Public Records

Same Entity

SATELEC-ACTEON GROUP
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
2243757 ACTEON, INC. Mount Laurel, NJ, US
9615782 SOPRO LA CIOTAT CEDEX Bouches-du-Rhone, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K832443 California Technics, Inc. ULTRASONIC DENTAL PROPHYLAXIS UNIT 1983-09-12
K994299 Bonart Co., Ltd. ART-P3, MODEL P3-1-ART-A1 2000-03-06
K932506 Rudolf Riester GmbH & Co. KG RI-SCOPE (S) 1993-10-08
K040153 Indigenous Peoples Technology and Education Center I-TEC PORTABLE DENTAL OPERATORY 2004-05-21
K243921 Foshan Coxo Medical Instrument Co., Ltd. LED Curing Lights (DB686 HALO) 2025-04-11

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044015. Last updated year: 2026. Please use registration number 8044015 when referencing this establishment in official correspondence.
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