PREMIER MEDICAL

Contract manufacturer · Philadelphia, PA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration: 2521453 (openFDA record; or search FDA's registration database)
FEI number: 2521453
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer; Repackager or relabeler
Owner or operator: Premier Dental Products Company (FDA owner/operator no. 2511556)
Registered address: 10090 SANDMEYER LN., Philadelphia, PA 19116
Contract listings: 52 device listings, 52 product codes, first listed Dec 15, 1977
Certification: Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product code	Device (FDA name)	Class	Category	Role	First listed
BTO	Tube, Tracheostomy (W/Wo Connector)	Class II	Anesthesiology	Contract manufacturing	Nov 7, 2007
DZN	Instruments, Dental Hand	Class I	Dental	Contract manufacturing	Oct 4, 2019
EFC	Warmer, Anesthetic Tube	Class I	Dental	Contract manufacturing	Dec 15, 1977
EHJ	Disk, Abrasive	Class I	Dental	Contract manufacturing	Mar 22, 2005
EHY	Tray, Impression, Preformed	Class I	Dental	Contract manufacturing	May 5, 1980
EIG	Retractor, All Types	Class I	Dental	Contract manufacturing	Jan 23, 2002
EIK	Carver, Wax, Dental	Class I	Dental	Contract manufacturing	Jan 14, 2002
EIL	Gauge, Depth, Instrument, Dental	Class I	Dental	Contract manufacturing	Jan 23, 2002
EIS	Remover, Crown	Class I	Dental	Contract manufacturing	Dec 15, 1977
EIX	Probe, Periodontic	Class I	Dental	Contract manufacturing	Jun 7, 1996
EIY	Instrument, Filling, Plastic, Dental	Class I	Dental	Contract manufacturing	Jul 16, 1991
EJB	Handle, Instrument, Dental	Class I	Dental	Contract manufacturing	Jan 23, 2002
EJQ	Wheel, Polishing Agent	Class I	Dental	Contract manufacturing	Jun 15, 2023
EJZ	Knife, Margin Finishing, Operative	Class I	Dental	Contract manufacturing	Jan 23, 2002
EKB	Explorer, Operative	Class I	Dental	Contract manufacturing	Jan 14, 2002
EKC	Excavator, Dental, Operative	Class I	Dental	Contract manufacturing	Jan 14, 2002
EKD	Instrument, Cutting, Operative	Class I	Dental	Contract manufacturing	Jan 23, 2002
EKG	Condenser, Amalgam And Foil, Operative	Class I	Dental	Contract manufacturing	Jan 14, 2002
EKH	Carver, Dental Amalgam, Operative	Class I	Dental	Contract manufacturing	Jan 14, 2002
EKI	Carrier, Amalgam, Operative	Class I	Dental	Contract manufacturing	Dec 15, 1977
EKJ	Burnisher, Operative	Class I	Dental	Contract manufacturing	Jan 14, 2002
EKK	Spreader, Pulp Canal Filling Material, Endodontic	Class I	Dental	Contract manufacturing	Oct 28, 1993
EKR	Plugger, Root Canal, Endodontic	Class I	Dental	Contract manufacturing	Oct 28, 1993
ELA	Instrument, Hand, Calculus Removal	Class I	Dental	Contract manufacturing	Jan 23, 2002
ELC	Scaler, Ultrasonic	Class II	Dental	Contract manufacturing	Apr 24, 2008
EMI	File, Bone, Surgical	Class I	Dental	Contract manufacturing	Jan 14, 2002
EMJ	Elevator, Surgical, Dental	Class I	Dental	Contract manufacturing	Jan 14, 2002
EMK	Curette, Surgical, Dental	Class I	Dental	Contract manufacturing	Jan 14, 2002
EML	Chisel, Bone, Surgical	Class I	Dental	Contract manufacturing	Jan 14, 2002
EMN	Scaler, Periodontic	Class I	Dental	Contract manufacturing	Oct 7, 2009
EMO	Knife, Periodontic	Class I	Dental	Contract manufacturing	Jan 23, 2002
EMR	File, Periodontic	Class I	Dental	Contract manufacturing	Jan 23, 2002
EMS	Curette, Periodontic	Class I	Dental	Contract manufacturing	Jan 14, 2002
ETF	Unit, Examining/Treatment, Ent	Class I	Ear, nose and throat	Contract manufacturing	Feb 16, 1995
EZB	Stylet For Catheter, Gastro-Urology	Class I	Gastroenterology and urology	Contract manufacturing	Oct 27, 2015
FGM	Probe And Director, Gastro-Urology	Class I	Gastroenterology and urology	Contract manufacturing	Aug 26, 1992
FZS	Curette, Surgical, General Use	Class I	General and plastic surgery	Contract manufacturing	Aug 26, 1992
GAD	Retractor	Class I	General and plastic surgery	Contract manufacturing	Aug 26, 1992
GDM	Needle, Aspiration And Injection, Reusable	Class I	General and plastic surgery	Contract manufacturing	Sep 29, 1998
GEH	Unit, Cryosurgical, Accessories	Class II	General and plastic surgery	Contract manufacturing	Nov 7, 2007
GEI	Electrosurgical, Cutting & Coagulation & Accessories	Class II	General and plastic surgery	Contract manufacturing	Nov 7, 2007
GFJ	Mallet, Surgical, General & Plastic Surgery	Class I	General and plastic surgery	Contract manufacturing	Oct 19, 1998
HCY	Curette, Uterine	Class I	Obstetrics and gynecology	Contract manufacturing	Sep 29, 1998
HDQ	Dilator, Cervical, Fixed Size	Class I	Obstetrics and gynecology	Contract manufacturing	Sep 29, 1998
HHF	Remover, Intrauterine Device, Contraceptive, Hook-Type	Class I	Obstetrics and gynecology	Contract manufacturing	Aug 26, 1992
HHM	Sound, Uterine	Class I	Obstetrics and gynecology	Contract manufacturing	Sep 29, 1998
HIG	Insufflator, Hysteroscopic	Class II	Obstetrics and gynecology	Contract manufacturing	Nov 7, 2007
JCC	Ph Buffer	Class I	Pathology	Contract manufacturing	Nov 11, 2024
JYG	Curette, Ear	Class I	Ear, nose and throat	Contract manufacturing	Aug 26, 1992
JZF	Tube, Ear Suction	Class I	Ear, nose and throat	Contract manufacturing	Feb 6, 2002
KAC	Tube, Laryngectomy	Class I	Ear, nose and throat	Contract manufacturing	Feb 6, 2002
KAM	Cannula, Sinus	Class I	General and plastic surgery	Contract manufacturing	Feb 6, 2002