FDA Registration
Active
🇺🇸 United States
PREMIER MEDICAL
Reg #: 2521453
·
FEI: 2521453
·
Expires 2026
Products
54
Proprietary Names
77
Establishment Types
2
Classifications
54
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Registration Details
- Registration Name
- PREMIER MEDICAL
- Registration Number
- 2521453
- FEI Number
- 2521453
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10090 SANDMEYER LN.
- City
- PHILADELPHIA
- State
- PA
- ZIP
- 19116
- Country
- US
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Remover, Crown | EIS | Class 1 | Dental | No | 1977-12-15 |
| Retainer, Matrix | JEP | Class 1 | Dental | No | 1977-12-15 |
| Curette, Uterine | HCY | Class 1 | Obstetrics/Gynecology | No | 1998-09-29 |
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 2002-01-23 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 1998-10-19 |
| Knife, Periodontic | EMO | Class 1 | Dental | No | 2002-01-23 |
| Plugger, Root Canal, Endodontic | EKR | Class 1 | Dental | No | 1993-10-28 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2002-01-14 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 1992-08-26 |
| File, Periodontic | EMR | Class 1 | Dental | No | 2002-01-23 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2019-10-04 |
| Carrier, Amalgam, Operative | EKI | Class 1 | Dental | No | 1977-12-15 |
| Condenser, Amalgam And Foil, Operative | EKG | Class 1 | Dental | No | 2002-01-14 |
| Spreader, Pulp Canal Filling Material, Endodontic | EKK | Class 1 | Dental | No | 1993-10-28 |
| Tube, Tracheostomy (W/Wo Connector) | BTO | Class 2 | Anesthesiology | No | 2007-11-07 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 1998-09-29 |
| Carver, Wax, Dental | EIK | Class 1 | Dental | No | 2002-01-14 |
| Warmer, Anesthetic Tube | EFC | Class 1 | Dental | No | 1977-12-15 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2002-02-06 |
| Knife, Margin Finishing, Operative | EJZ | Class 1 | Dental | No | 2002-01-23 |
| Cotton, Roll | EFN | Class 1 | Dental | No | 2009-06-03 |
| Dilator, Cervical, Fixed Size | HDQ | Class 1 | Obstetrics/Gynecology | No | 1998-09-29 |
| Sound, Uterine | HHM | Class 1 | Obstetrics/Gynecology | No | 1998-09-29 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2008-04-24 |
| Scaler, Periodontic | EMN | Class 1 | Dental | No | 2009-10-07 |
| Ph Buffer | JCC | Class 1 | Pathology | No | 2024-11-11 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2005-03-22 |
| File, Bone, Surgical | EMI | Class 1 | Dental | No | 2002-01-14 |
| Tube, Ear Suction | JZF | Class 1 | Ear, Nose, Throat | No | 2002-02-06 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2002-01-23 |
| Remover, Intrauterine Device, Contraceptive, Hook-Type | HHF | Class 1 | Obstetrics/Gynecology | No | 1992-08-26 |
| Stylet For Catheter, Gastro-Urology | EZB | Class 1 | Gastroenterology, Urology | No | 2015-10-27 |
| Carver, Dental Amalgam, Operative | EKH | Class 1 | Dental | No | 2002-01-14 |
| Probe And Director, Gastro-Urology | FGM | Class 1 | Gastroenterology, Urology | No | 1992-08-26 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2002-01-23 |
| Burnisher, Operative | EKJ | Class 1 | Dental | No | 2002-01-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-11-07 |
| Unit, Examining/Treatment, Ent | ETF | Class 1 | Ear, Nose, Throat | No | 1995-02-16 |
| Excavator, Dental, Operative | EKC | Class 1 | Dental | No | 2002-01-14 |
| Probe, Periodontic | EIX | Class 1 | Dental | No | 1996-06-07 |
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2002-01-23 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1992-08-26 |
| Unit, Cryosurgical, Accessories | GEH | Class 2 | General, Plastic Surgery | No | 2007-11-07 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 1980-05-05 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 2002-01-23 |
| Curette, Ear | JYG | Class 1 | Ear, Nose, Throat | No | 1992-08-26 |
| Curette, Surgical, Dental | EMK | Class 1 | Dental | No | 2002-01-14 |
| Curette, Periodontic | EMS | Class 1 | Dental | No | 2002-01-14 |
| Insufflator, Hysteroscopic | HIG | Class 2 | Obstetrics/Gynecology | No | 2007-11-07 |
| Tube, Laryngectomy | KAC | Class 1 | Ear, Nose, Throat | No | 2002-02-06 |
| Elevator, Surgical, Dental | EMJ | Class 1 | Dental | No | 2002-01-14 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 2023-06-15 |
| Explorer, Operative | EKB | Class 1 | Dental | No | 2002-01-14 |
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 1991-07-16 |
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 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 KNIVES
Premier Retraction Caps
PREMIER CERVICAL DILATOR
PREMIER UTERINE SOUND
Premier Ultrasonic Scaler
BufferPro
Premier Poli-Pro polishing System
PREMIER BONE FILE
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
Nitrospray Plus
First Bite
Zhermack
T-LOC Triple Tray
Bite-Tray
Premier® Triple Tray®
NeoTray
Nice Bite
Quala
Emulate
Maxima Tray
Alfa
AccuBite
PREMIER SCALERS
PREMIER SURGICAL CURETTE
PREMIER PERIODONTIC CURETTE
Jarcho / Kahn
PREMIER LARYNGECTOMY TUBES
PREMIER SURGICAL ELEVATOR
Diamond Twist SCL
Diamond Twist SCO
PREMIER EXPLORER
PREMIER PLASTIC FILLIN
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device