Power Dental USA, Inc.

FDA Device Registration & Listing · McHenry, IL, US · Registration 3003969055

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
3003969055
FEI Number
3003969055
Entity Name
Power Dental USA, Inc.
City/State/Country
McHenry, IL, US
Establishment Address
2809 Barney Ct, McHenry, IL 60051, US
Establishment Type(s)
Remanufacture Medical Device,Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Power Dental USA (Owner Number: 10028819)
Owner / Operator Contact Address
2809 Barney Ct, McHenry, IL 60051, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TRAY, SURGICAL, INSTRUMENT FILE, PERIODONTIC HOE, PERIODONTIC OSTEOTOME Headlamp STARTER, BONE SCREW FORCEPS, RONGEUR, SURGICAL SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL CARRIER, AMALGAM, OPERATIVE Elevator HEMOSTAT, SURGICAL CLAMP, TOWEL File, Bone, Surgical INSTRUMENT, MANUAL, SURGICAL, GENERAL USE SCALER, PERIODONTIC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2013-05-14
EMR File, Periodontic Dental Class 1 872.4565 2021-05-21
EIS Remover, Crown Dental Class 1 872.4565 2009-03-10
EKC Excavator, Dental, Operative Dental Class 1 872.4565 2009-03-10
EJL Bur, Dental Dental Class 1 872.3240 2013-03-04
EMQ Hoe, Periodontic Dental Class 1 872.4565 2021-05-21
EMJ Elevator, Surgical, Dental Dental Class 1 872.4565 2009-03-10
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2011-12-15
EJZ Knife, Margin Finishing, Operative Dental Class 1 872.4565 2009-03-10
DZN Instruments, Dental Hand Dental Class 1 872.4565 2011-12-15
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2017-02-20
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 2021-05-21
EFL Forceps, Dressing, Dental Dental Class 1 872.4565 2011-11-02
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2011-11-02
GFJ Mallet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2011-11-02
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2009-03-10
ECS Pusher, Band, Orthodontic Dental Class 1 872.4565 2011-11-02
HPP Headlamp, Operating, Battery-Operated Ophthalmic Class 1 886.4335 2021-11-19
EIG Retractor, All Types Dental Class 1 872.4565 2011-11-16
HXZ Cutter, Wire Orthopedic Class 1 888.4540 2011-12-16
HWD Starter, Bone Screw Orthopedic Class 1 888.4540 2013-03-04
EMH Forceps, Rongeur, Surgical Dental Class 1 872.4565 2021-05-21
EKK Spreader, Pulp Canal Filling Material, Endodontic Dental Class 1 872.4565 2011-12-15
EID Syringe, Restorative And Impression Material Dental Class 1 872.4565 2021-06-02
FTX Mirror, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2011-11-02
LRW Scissors, General, Surgical General, Plastic Surgery Class 1 878.4800 2011-11-02
EIC Syringe, Periodontic, Endodontic, Irrigating Dental Class 1 872.4565 2011-11-02
EKI Carrier, Amalgam, Operative Dental Class 1 872.4565 2021-05-21
EIY Instrument, Filling, Plastic, Dental Dental Class 1 872.4565 2009-03-10
HTE Elevator General, Plastic Surgery Class 1 878.4800 2018-06-26
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2011-11-02
EJB Handle, Instrument, Dental Dental Class 1 872.4565 2011-11-02
EMD Hemostat, Surgical Dental Class 1 872.4565 2021-06-04
HXD Clamp General, Plastic Surgery Class 1 878.4800 2021-05-21
HRQ Hemostat General, Plastic Surgery Class 1 878.4800 2011-12-15
HBD Handpiece (Brace), Drill Neurology Class 1 882.4325 2016-05-02
EMI File, Bone, Surgical Dental Class 1 872.4565 2021-06-02
JEX Plier, Orthodontic Dental Class 1 872.4565 2011-11-02
EKB Explorer, Operative Dental Class 1 872.4565 2009-03-10
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2021-05-21
EKR Plugger, Root Canal, Endodontic Dental Class 1 872.4565 2009-03-10
KBN Gag, Mouth Ear, Nose, Throat Class 1 874.4420 2011-11-02
JEP Retainer, Matrix Dental Class 1 872.4565 2013-03-04
EMN Scaler, Periodontic Dental Class 1 872.4565 2021-05-21
EMK Curette, Surgical, Dental Dental Class 1 872.4565 2009-03-10
EBH Material, Impression Tray, Resin Dental Class 1 872.3670 2011-12-16
EKE Curette, Operative Dental Class 1 872.4565 2009-03-10
HWK Trephine Orthopedic Class 1 888.4540 2013-03-04
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2011-11-02
ECP Instrument, Ligature Tucking, Orthodontic Dental Class 1 872.4565 2011-11-02
EKJ Burnisher, Operative Dental Class 1 872.4565 2009-03-10

Official Correspondent

Jang Lim

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Power Dental USA
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K831136 Almore Intl., Inc. DOUBLE BOW TOOTH SEPARATOR 1983-06-08
K851721 Artiberia 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS 1985-07-02
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2016 Zimmer, Inc. 1
Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.
Z-0039-2018 Teleflex Medical 1
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003969055. Last updated year: 2026. Please use registration number 3003969055 when referencing this establishment in official correspondence.
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