Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2521453

FEI Number

2521453

Entity Name

PREMIER MEDICAL

City/State/Country

PHILADELPHIA, PA, US

Establishment Address

10090 SANDMEYER LN., PHILADELPHIA, PA 19116, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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 Premier X5 Wedge Medium Green-Qty 100 Premier X5 Sample Pack Premier X5 Matrix Refill 4.5 mm -Qty 80 Premier X5 Wedge Small Yellow-Qty 100 Premier X5 Matrix Pin Holder Premier X5 Essential Kit- No Instruments Premier X5 Matrix Refill 6.5 mm -Qty 80 Premier X5 Intro Kit Premier X5 Forceps Premier X5 Matrix Refill 5.5 mm -Qty 80 Premier X5 Matrix Refill 3.5 mm -Qty 25 Premier X5 Ring Universal- Qty 35 Premier X5 Wedge Large Blue-Qty 100 Cure-Thru Sycamore Wood Wedges VeneerNow PREMIER UTERINE CURETTE Black Cutting Instrument Black Cutting Hatchet Calif Cutting Instrument PREMIER MALLET PREMIER PERIODONTIC KNIVES Premier Endodontic Pluggers Premier Premier Curette PREMIER PERIODONTIC FILE Premier Dental Products Company AMALGAM PREMIER AMALGAM CONDENSER Premier Endodontic Spreaders Premier Tracheostomy Tubes PREMIER PELLET INSERTER PREMIER WAX CARVER Premier Cartridge Warmer Premier PREMIER KNIVES Premier Retraction Caps PREMIER CERVICAL DILATOR PREMIER UTERINE SOUND Premier Ultrasonic Scaler Premier BufferPro Premier Poli-Pro polishing System PREMIER BONE FILE Premier PREMIER INSTRUMENT HANDLE PREMIER IUD REMOVAL HOOK PREMIER AMALGAM CARVER PREMIER OPERATING PREMIER RETRACTORS PREMIER OPERATIVE BURNISHER Premier Loop and Ball Electrodes PREMIER MIRROR WARMER PREMIER EXCAVATOR PERIOWISE PERIODONTAL PROBE PREMIER DEPTH GAUGE PREMIER RETRACTOR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIS	Remover, Crown	Dental	Class 1	872.4565	1977-12-15
JEP	Retainer, Matrix	Dental	Class 1	872.4565	1977-12-15
HCY	Curette, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1998-09-29
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2002-01-23
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1998-10-19
EMO	Knife, Periodontic	Dental	Class 1	872.4565	2002-01-23
EKR	Plugger, Root Canal, Endodontic	Dental	Class 1	872.4565	1993-10-28
EML	Chisel, Bone, Surgical	Dental	Class 1	872.4565	2002-01-14
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1992-08-26
EMR	File, Periodontic	Dental	Class 1	872.4565	2002-01-23
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2019-10-04
EKI	Carrier, Amalgam, Operative	Dental	Class 1	872.4565	1977-12-15
EKG	Condenser, Amalgam And Foil, Operative	Dental	Class 1	872.4565	2002-01-14
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Dental	Class 1	872.4565	1993-10-28
BTO	Tube, Tracheostomy (W/Wo Connector)	Anesthesiology	Class 2	868.5800	2007-11-07
GDM	Needle, Aspiration And Injection, Reusable	General, Plastic Surgery	Class 1	878.4800	1998-09-29
EIK	Carver, Wax, Dental	Dental	Class 1	872.4565	2002-01-14
EFC	Warmer, Anesthetic Tube	Dental	Class 1	872.6100	1977-12-15
KAM	Cannula, Sinus	General, Plastic Surgery	Class 1	878.4800	2002-02-06
EJZ	Knife, Margin Finishing, Operative	Dental	Class 1	872.4565	2002-01-23
EFN	Cotton, Roll	Dental	Class 1	872.6050	2009-06-03
HDQ	Dilator, Cervical, Fixed Size	Obstetrics/Gynecology	Class 1	884.4530	1998-09-29
HHM	Sound, Uterine	Obstetrics/Gynecology	Class 1	884.4530	1998-09-29
ELC	Scaler, Ultrasonic	Dental	Class 2	872.4850	2008-04-24
EMN	Scaler, Periodontic	Dental	Class 1	872.4565	2009-10-07
JCC	Ph Buffer	Pathology	Class 1	864.4010	2024-11-11
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2005-03-22
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2002-01-14
JZF	Tube, Ear Suction	Ear, Nose, Throat	Class 1	874.4420	2002-02-06
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2002-01-23
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Obstetrics/Gynecology	Class 1	884.4530	1992-08-26
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	Class 1	876.5130	2015-10-27
EKH	Carver, Dental Amalgam, Operative	Dental	Class 1	872.4565	2002-01-14
FGM	Probe And Director, Gastro-Urology	Gastroenterology, Urology	Class 1	876.4730	1992-08-26
EIG	Retractor, All Types	Dental	Class 1	872.4565	2002-01-23
EKJ	Burnisher, Operative	Dental	Class 1	872.4565	2002-01-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2007-11-07
ETF	Unit, Examining/Treatment, Ent	Ear, Nose, Throat	Class 1	874.5300	1995-02-16
EKC	Excavator, Dental, Operative	Dental	Class 1	872.4565	2002-01-14
EIX	Probe, Periodontic	Dental	Class 1	872.4565	1996-06-07
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2002-01-23
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1992-08-26

Official Correspondent

No official correspondent registered.

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
2511556	PREMIER DENTAL PRODUCTS CO.	PLYMOUTH MEETING, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
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
K851721	Artiberia	1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS	1985-07-02
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
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-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2521453. Last updated year: 2026. Please use registration number 2521453 when referencing this establishment in official correspondence.