Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2511556

FEI Number

2511556

Entity Name

PREMIER DENTAL PRODUCTS CO.

City/State/Country

PLYMOUTH MEETING, PA, US

Establishment Address

1710 Romano Dr, PLYMOUTH MEETING, PA 19462, US

Establishment Type(s)

Repack or Relabel Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Premier Dental Products Company (Owner Number: 2511556)

Owner / Operator Contact Address

1710 ROMANO DR., --, Plymouth Meeting, PA 19462, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Premier 2001e Electrosurgical Unit Premier Endodontic Spreaders Diamond Twist SCL Diamond Twist SCO PREMIER CERVICAL DILATOR PREMIER LARYNGECTOMY TUBES Sleeve-It PREMIER AMALGAM CARVER Jarcho / Kahn Premier Pessary AND CROWN COLLAR Podiatry Burs Black Cutting Instrument Black Cutting Hatchet Calif Cutting Instrument INTEGRA POST PREMIER SURGICAL CURETTE Premier ENAMEL PRO VARNISH TruCone Premier Cervical Tenaculum MultiMatch PREMIER DEPTH GAUGE PREMIER SUCTION CANNULA TUBE PREMIER PLASTIC FILLIN Hemodent Pro Clean Premier BioGreen Biodegradable Micro-Applicators PREMIER WAX CARVER CompCore AF PREMIER SCALERS Premier Loop and Ball Electrodes PREMIER IUD REMOVAL HOOK Premier Absorbent Points Premier® Kevorkian Biopsy Forceps Premier® Tischler Biopsy Forceps Premier® Burke Biopsy Forceps Premier® Baby Tischler Biopsy Forceps Knit-Pak+ Cord Knit-Pak Cord Denmat Ceri-Sander PREMIER RETRACTOR PREMIER KNIVES PREMIER VAGINAL RETRACTOR Premier Curette PREMIER SURGICAL ELEVATOR Premier Spot-On Etch CRYOMEGA AeroPro Cordless Prophy System PREMIER EXPLORER AMALGAM Premier Implant Cement Premier Acetic-Acid PREMIER OSTEOTOME CHISEL PREMIER PERIODONTIC KNIVES Premier Premier Bond-PR SOLO DIAMOND PREMIER PELLET INSERTER Nitrospray Plus BufferPro PREMIER MALLET RC PREP ZR-Cem PREMIER BONE FILE PREMIER RETRACTORS PREMIER OPERATIVE BURNISHER Premier First Bite Zhermack T-LOC Triple Tray Bite-Tray Premier® Triple Tray® NeoTray Nice Bite Quala Emulate Maxima Tray Alfa AccuBite PREMIER INSTRUMENT HANDLE Izzo Porcelain Silane Premier Ultrasonic Scaler Premier DENTAL ARTICULATORS W.O.W. Premier Cartridge Warmer PREMIER PERIODONTIC FILE DENTAL PLIERS BOND BOOST SE Premier® 2pro® Disposable Prophy Angle Premier® ProFlare Disposable Prophy Angle FORCEPS RUBBER DAM CLAMP Premier Removalon Brite Shield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-09
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	1993-10-28
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2023-06-15
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	1998-09-29
KAC	Tube, Laryngectomy	Ear, Nose, Throat	Class 1	874.4420	2002-02-06
PEM	Dental Barriers And Sleeves	General, Plastic Surgery	Class 2	878.4370	2019-07-29
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2002-01-14
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2007-11-07
HHW	Pessary, Vaginal	Obstetrics/Gynecology	Class 2	884.3575	2009-05-20
EIR	Scissors, Collar And Crown	Dental	Class 1	872.4565	1977-12-15
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2011-02-08
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2002-01-23
ELR	Post, Root Canal	Dental	Class 1	872.3810	1998-02-05
EMK	Curette, Surgical, Dental	Dental	Class 1	872.4565	2002-01-14
EIS	Remover, Crown	Dental	Class 1	872.4565	1977-12-15
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2006-12-04
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2010-05-19
PUA	Tenaculum, Uterine, Exempt	Obstetrics/Gynecology	Class 2	884.4530	2023-06-06
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2022-12-14
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2002-01-23
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-09-29
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	1991-07-16
MVL	Cord, Retraction	Unknown	Class U	N/A	2023-06-14
JER	Cleaner, Denture, Mechanical	Dental	Class 1	872.3530	2022-05-23
EGN	Scissors, Surgical Tissue, Dental	Dental	Class 1	872.4565	1977-12-15
KXR	Applicator, Resin	Dental	Class 1	872.3140	2021-04-26
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2002-01-14
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-11-07
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	2002-01-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-07
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	1992-08-26
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	2023-06-15
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	2023-06-06
MVL	Cord, Retraction	Unknown	Class U	N/A	2013-12-23
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2023-06-15
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1992-08-26
EJZ	Knife, Margin Finishing, Operative	Dental	Class 1	872.4565	2002-01-23
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	1998-09-29
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1992-08-26
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2002-01-14
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2023-06-14
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2010-12-21
EKX	Handpiece, Direct Drive, Ac-Powered	Dental	Class 1	872.4200	2019-03-05
EKB	Explorer, Operative	Dental	Class 1	872.4565	2002-01-14
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	1977-12-15
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-11-07
IGF	Solution, Formalin-Alcohol-Acetic Acid	Pathology	Class 1	864.4010	2016-02-19
EMM	Chisel, Osteotome, Surgical	Dental	Class 1	872.4565	2002-01-14
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2002-01-23
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2002-02-06
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2002-02-06
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2026-04-02
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2026-04-02
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	1977-12-15
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	1998-09-29
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2007-11-07
JCC	Ph Buffer	Pathology	Class 1	864.4010	2024-11-11
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-10-19
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	1993-10-28
EMA	Cement, Dental	Dental	Class 2	872.3275	2019-12-09
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2002-01-14
EIG	Retractor, All Types	Dental	Class 1	872.4565	2002-01-23
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2002-01-14
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	1980-05-05
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2002-01-23
JEQ	Toothbrush, Powered	Dental	Class 1	872.6865	2021-12-28
ELL	Teeth, Porcelain	Dental	Class 2	872.3920	2010-03-05
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2008-04-24
JYG	Curette, Ear	Ear, Nose, Throat	Class 1	874.4420	1992-08-26
EJP	Articulators	Dental	Class 1	872.3150	2006-05-22
EFC	Warmer, Anesthetic Tube	Dental	Class 1	872.6100	1977-12-15
EMR	File, Periodontic	Dental	Class 1	872.4565	2002-01-23
EJY	Pliers, Operative	Dental	Class 1	872.4565	1977-12-15
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2006-10-27
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2009-11-11
EJG	Forceps, Rubber Dam Clamp	Dental	Class 1	872.6300	1977-12-15
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2009-10-07
FLG	Cleaner, Ultrasonic, Medical Instrument	General Hospital	Class 1	880.6150	2022-05-23

Official Correspondent

Jessica Huang

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Premier Dental Products Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2521453	PREMIER MEDICAL	PHILADELPHIA, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0008-2013	Gynex Corporation	2	Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "*GYNEX* Electrode Handpiece, Foot Activated* Manufactured for GYNEX*" Gynex catalog number: 950 (Gynex REF 950, Electrode Handpiece) It connects the electrode to the food activated electric generator. Electrodes are used in gynecological procedures, in a physician's office, for cutting to remove tissue and coagulation to control bleeding by the use of high frequency current.
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0034-2012	X Spine Systems Inc	1	Axle Interspinous Fusion System Torque Driver Handle, Model #: X060-0323, Lot # 525941, S/Ns 001-017, Lot # 525942, S/Ns 001-050, Mfr. By: Bradshaw Medical Inc., Kenosha, WI 53144 The Axle Torque Driver Handle is used to lock the set screw into the locking plate.

Similar Registrations

Registration Number	Establishment Name	Location
3007353760	ENERGIST LIMITED	Swansea, GB
3005064998	RDI INC.	Mount Kisco, NY, US
3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2511556. Last updated year: 2026. Please use registration number 2511556 when referencing this establishment in official correspondence.