BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PREMIER DENTAL PRODUCTS CO.

    Reg #: 2511556 · FEI: 2511556 · Expires 2026
    View on FDA
    Products
    101
    Proprietary Names
    154
    Establishment Types
    4
    Classifications
    101

    Registration Details

    Registration Name
    PREMIER DENTAL PRODUCTS CO.
    Registration Number
    2511556
    FEI Number
    2511556
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1710 Romano Dr
    City
    PLYMOUTH MEETING
    State
    PA
    ZIP
    19462
    Country
    US

    Regulatory Submissions

    510(k) Number
    K945492

    Owner / Operator

    Firm Name
    Premier Dental Products Company
    Operator Number
    2511556
    Address
    1710 ROMANO DR., --
    City
    Plymouth Meeting
    State
    PA
    Postal Code
    19462
    Country
    US
    Correspondent
    Jessica Huang

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Spreader, Pulp Canal Filling Material, Endodontic EKK
    Wheel, Polishing Agent EJQ
    Dilator, Cervical, Fixed Size HDQ
    Tube, Laryngectomy KAC
    Dental Barriers And Sleeves PEM
    Carver, Dental Amalgam, Operative EKH
    Insufflator, Hysteroscopic HIG
    Pessary, Vaginal HHW
    Scissors, Collar And Crown EIR
    Brush, Dermabrasion, Powered GFE
    Instrument, Cutting, Operative EKD
    Post, Root Canal ELR
    Curette, Surgical, Dental EMK
    Remover, Crown EIS
    Varnish, Cavity LBH
    Electrocautery, Gynecologic (And Accessories) HGI
    Tenaculum, Uterine, Exempt PUA
    Material, Tooth Shade, Resin EBF
    Gauge, Depth, Instrument, Dental EIL
    Cannula, Surgical, General & Plastic Surgery GEA
    Instrument, Filling, Plastic, Dental EIY
    Cord, Retraction MVL
    Cleaner, Denture, Mechanical JER
    Scissors, Surgical Tissue, Dental EGN
    Applicator, Resin KXR
    Carver, Wax, Dental EIK
    Instrument, Hand, Calculus Removal ELA
    Remover, Intrauterine Device, Contraceptive, Hook-Type HHF
    Point, Paper, Endodontic EKN
    Forceps, Biopsy, Gynecological HFB
    Strip, Polishing Agent EHM
    Retractor GAD
    Knife, Margin Finishing, Operative EJZ
    Retractor, Vaginal HDL
    Curette, Surgical, General Use FZS
    Elevator, Surgical, Dental EMJ
    Agent, Tooth Bonding, Resin KLE
    Unit, Cryosurgical, Accessories GEH
    Handpiece, Direct Drive, Ac-Powered EKX
    Explorer, Operative EKB
    Carrier, Amalgam, Operative EKI
    Cement, Dental EMA
    Solution, Formalin-Alcohol-Acetic Acid IGF
    Chisel, Osteotome, Surgical EMM
    Knife, Periodontic EMO
    Cannula, Sinus KAM
    Tube, Ear Suction JZF
    Instrument, Diamond, Dental DZP
    Needle, Aspiration And Injection, Reusable GDM
    Ph Buffer JCC
    Mallet, Surgical, General & Plastic Surgery GFJ
    Preparer, Root Canal Endodontic EKQ
    File, Bone, Surgical EMI
    Retractor, All Types EIG
    Burnisher, Operative EKJ
    Tray, Impression, Preformed EHY
    Handle, Instrument, Dental EJB
    Toothbrush, Powered JEQ
    Teeth, Porcelain ELL
    Scaler, Ultrasonic ELC
    Curette, Ear JYG
    Articulators EJP
    Warmer, Anesthetic Tube EFC
    File, Periodontic EMR
    Pliers, Operative EJY
    Cup, Prophylaxis EHK
    Forceps, Rubber Dam Clamp EJG
    Scaler, Periodontic EMN
    Cleaner, Ultrasonic, Medical Instrument FLG
    Curette, Periodontic EMS
    Cutter, Surgical FZT
    Retainer, Matrix JEP
    Curette, Uterine HCY
    Drill, Dental, Intraoral DZA
    Disk, Abrasive EHJ
    Punch, Surgical LRY
    Cleanser, Root Canal KJJ
    Tube, Tracheostomy (W/Wo Connector) BTO
    Syringe, Restorative And Impression Material EID
    Sealant, Pit And Fissure, And Conditioner EBC
    Sound, Uterine HHM
    Unit, Examining/Treatment, Ent ETF
    Probe And Director, Gastro-Urology FGM
    Instruments, Dental Hand DZN
    Accessory, Surgical Apparel LYU
    Wrap, Sterilization FRG
    Hemostat, Surgical EMD
    Adhesive, Bracket And Tooth Conditioner, Resin DYH
    Cotton, Roll EFN
    Excavator, Dental, Operative EKC
    Forceps, Articulation Paper EFK
    Probe, Periodontic EIX
    Forceps, Rongeur, Surgical EMH
    Brush, Cleaning, Tracheal Tube EPE
    Condenser, Amalgam And Foil, Operative EKG
    Solution, Lugol'S IAM
    Plugger, Root Canal, Endodontic EKR
    Speculum, Vaginal, Metal HDF
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Forceps, Tooth Extractor, Surgical EMG

    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 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 Bond-PR SOLO DIAMOND PREMIER PELLET INSERTER Nitrospray Plus BufferPro PREMIER MALLET RC PREP ZR-Cem PREMIER BONE FILE PREMIER RETRACTORS PREMIER OPERATIVE BURNISHER 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 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 Removalon Brite Shield PREMIER PERIODONTIC CURETTE Premier® English Anvil Nail Splitter 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 Traxodent INTEGRA POST DRILLS Premier Poli-Pro polishing System Uni-Punch RC-Prep Premier Decannulation Stopper MultiMatch Flow MICRODOSE SYRINGE Itena NexTemp Biocoat Mix-Tips BioCoat PREMIER UTERINE SOUND PREMIER MIRROR WARMER Premier Tracheostomy Tubes PREMIER OPERATING Premier Dental Products Company Face Shield Mark I Mark VI Mark IV Premier Accessory Cassette TastyTooth Varnish Premier Ceramic Primer HEMOSTAT MultiMatch Flow Chameleon AntiMicrobial Composite Premier Retraction Caps PREMIER EXCAVATOR Premier® Forceps - Articulation Paper PERIOWISE PERIODONTAL PROBE Tracheal Tube Brushes PREMIER AMALGAM CONDENSER Premier Lugol's PREMIER TEMPORARY CEMENT Premier Endodontic Pluggers PREMIER VAGINAL SPECULUM Premier IntegraBond Diamond Paste Enamel Pro Prophy Paste

    Establishment Types

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