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Data / Medical devices / United States / Premier Dental Products Co.

Premier Dental Products Co.: FDA-registered device maker in Plymouth Meeting, PA, United States, 30 510(k) clearances

Premier Dental Products Co. is registered with the FDA (registration 2511556) in Plymouth Meeting, PA, United States. It lists 101 device types. The FDA files 30 510(k) clearances under its listings, the newest dated March 3, 2026. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Premier Dental Products Co.
FDA registration number
2511556
Address
1710 Romano Dr, Plymouth Meeting, PA, United States, 19462
Owner or operator
Premier Dental Products Company (2511556)
Roles
Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed
December 15, 1977
Registered through
2026
Brand names listed
AMALGAM, AND CROWN, AccuBite, AeroPro Cordless Prophy System, Alfa, BOND BOOST SE, BioCoat, BioGreen Biodegradable Micro-Applicators and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Repackager or relabeler, Specification developeraccessdata.fda.gov
Adhesive, Bracket And Tooth Conditioner, ResinDYH2Complaint file establishment, Specification developeraccessdata.fda.gov
Agent, Polishing, Abrasive, Oral CavityEJR1Specification developeraccessdata.fda.gov
Agent, Tooth Bonding, ResinKLE2Complaint file establishment, Specification developeraccessdata.fda.gov
Applicator, ResinKXR1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
ArticulatorsEJP1Specification developeraccessdata.fda.gov
Brush, Cleaning, Tracheal TubeEPE1Repackager or relabeler, Specification developeraccessdata.fda.gov
Brush, Dermabrasion, PoweredGFE1Specification developeraccessdata.fda.gov
Burnisher, OperativeEKJ1Specification developeraccessdata.fda.gov
Cannula, SinusKAM1Specification developeraccessdata.fda.gov
Cannula, Surgical, General & Plastic SurgeryGEA1Specification developeraccessdata.fda.gov
Carrier, Amalgam, OperativeEKI1Specification developeraccessdata.fda.gov
Carver, Dental Amalgam, OperativeEKH1Specification developeraccessdata.fda.gov
Carver, Wax, DentalEIK1Specification developeraccessdata.fda.gov
Cement, DentalEMA2Specification developeraccessdata.fda.gov
Chisel, Osteotome, SurgicalEMM1Specification developeraccessdata.fda.gov
Cleaner, Denture, MechanicalJER1Complaint file establishment, Specification developeraccessdata.fda.gov
Cleaner, Ultrasonic, Medical InstrumentFLG1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Cleanser, Root CanalKJJUSpecification developeraccessdata.fda.gov
Condenser, Amalgam And Foil, OperativeEKG1Specification developeraccessdata.fda.gov
Cord, RetractionMVLUSpecification developeraccessdata.fda.gov
Cotton, RollEFN1Specification developeraccessdata.fda.gov
Cup, ProphylaxisEHK1Repackager or relabeler, Specification developeraccessdata.fda.gov
Curette, EarJYG1Specification developeraccessdata.fda.gov
Curette, PeriodonticEMS1Specification developeraccessdata.fda.gov
Curette, Surgical, DentalEMK1Specification developeraccessdata.fda.gov
Curette, Surgical, General UseFZS1Specification developeraccessdata.fda.gov
Curette, UterineHCY1Specification developeraccessdata.fda.gov
Cutter, SurgicalFZT1Repackager or relabeler, Specification developeraccessdata.fda.gov
Dental Barriers And SleevesPEM2Repackager or relabeleraccessdata.fda.gov
Dilator, Cervical, Fixed SizeHDQ1Specification developeraccessdata.fda.gov
Disk, AbrasiveEHJ1Specification developeraccessdata.fda.gov
Drill, Dental, IntraoralDZA1Complaint file establishmentaccessdata.fda.gov
Electrocautery, Gynecologic (And Accessories)HGI2Specification developeraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Manufacturer, Specification developeraccessdata.fda.gov
Elevator, Surgical, DentalEMJ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Excavator, Dental, OperativeEKC1Specification developeraccessdata.fda.gov
Explorer, OperativeEKB1Specification developeraccessdata.fda.gov
File, Bone, SurgicalEMI1Specification developeraccessdata.fda.gov
File, PeriodonticEMR1Specification developeraccessdata.fda.gov
Forceps, Articulation PaperEFK1Repackager or relabeler, Specification developeraccessdata.fda.gov
Forceps, Biopsy, GynecologicalHFB1Repackager or relabeler, Specification developeraccessdata.fda.gov
Forceps, Rongeur, SurgicalEMH1Repackager or relabeleraccessdata.fda.gov
Forceps, Rubber Dam ClampEJG1Repackager or relabeleraccessdata.fda.gov
Forceps, Tooth Extractor, SurgicalEMG1Repackager or relabeleraccessdata.fda.gov
Gauge, Depth, Instrument, DentalEIL1Specification developeraccessdata.fda.gov
Handle, Instrument, DentalEJB1Specification developeraccessdata.fda.gov
Handpiece, Direct Drive, Ac-PoweredEKX1Specification developeraccessdata.fda.gov
Hemostat, SurgicalEMD1Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OperativeEKD1Complaint file establishment, Specification developeraccessdata.fda.gov
Instrument, Diamond, DentalDZP1Specification developeraccessdata.fda.gov
Instrument, Filling, Plastic, DentalEIY1Specification developeraccessdata.fda.gov
Instrument, Hand, Calculus RemovalELA1Specification developeraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeler, Specification developeraccessdata.fda.gov
Insufflator, HysteroscopicHIG2Specification developeraccessdata.fda.gov
Knife, Margin Finishing, OperativeEJZ1Specification developeraccessdata.fda.gov
Knife, PeriodonticEMO1Specification developeraccessdata.fda.gov
Mallet, Surgical, General & Plastic SurgeryGFJ1Specification developeraccessdata.fda.gov
Material, Tooth Shade, ResinEBF2Complaint file establishment, Specification developeraccessdata.fda.gov
Needle, Aspiration And Injection, ReusableGDM1Repackager or relabeler, Specification developeraccessdata.fda.gov
Pessary, VaginalHHW2Specification developeraccessdata.fda.gov
Ph BufferJCC1Complaint file establishment, Specification developeraccessdata.fda.gov
Pliers, OperativeEJY1Repackager or relabeleraccessdata.fda.gov
Plugger, Root Canal, EndodonticEKR1Specification developeraccessdata.fda.gov
Point, Paper, EndodonticEKN1Specification developeraccessdata.fda.gov
Post, Root CanalELR1Repackager or relabeler, Specification developeraccessdata.fda.gov
Preparer, Root Canal EndodonticEKQ1Specification developeraccessdata.fda.gov
Probe And Director, Gastro-UrologyFGM1Specification developeraccessdata.fda.gov
Probe, PeriodonticEIX1Specification developeraccessdata.fda.gov
Punch, SurgicalLRY1Specification developeraccessdata.fda.gov
Remover, CrownEIS1Specification developeraccessdata.fda.gov
Remover, Intrauterine Device, Contraceptive, Hook-TypeHHF1Specification developeraccessdata.fda.gov
Retainer, MatrixJEP1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
RetractorGAD1Specification developeraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeler, Specification developeraccessdata.fda.gov
Retractor, VaginalHDL1Specification developeraccessdata.fda.gov
Scaler, PeriodonticEMN1Specification developeraccessdata.fda.gov
Scaler, UltrasonicELC2Specification developeraccessdata.fda.gov
Scissors, Collar And CrownEIR1Repackager or relabeleraccessdata.fda.gov
Scissors, Surgical Tissue, DentalEGN1Repackager or relabeleraccessdata.fda.gov
Sealant, Pit And Fissure, And ConditionerEBC2Complaint file establishment, Specification developeraccessdata.fda.gov
Solution, Formalin-Alcohol-Acetic AcidIGF1Specification developeraccessdata.fda.gov
Solution, Lugol'SIAM1Specification developeraccessdata.fda.gov
Sound, UterineHHM1Specification developeraccessdata.fda.gov
Speculum, Vaginal, MetalHDF1Repackager or relabeler, Specification developeraccessdata.fda.gov
Spreader, Pulp Canal Filling Material, EndodonticEKK1Specification developeraccessdata.fda.gov
Strip, Polishing AgentEHM1Specification developeraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Complaint file establishment, Repackager or relabeler, Specification developeraccessdata.fda.gov
Teeth, PorcelainELL2Specification developeraccessdata.fda.gov
Tenaculum, Uterine, ExemptPUA2Specification developeraccessdata.fda.gov
Toothbrush, PoweredJEQ1Specification developeraccessdata.fda.gov
Tray, Impression, PreformedEHY1Specification developeraccessdata.fda.gov
Tube, Ear SuctionJZF1Specification developeraccessdata.fda.gov
Tube, LaryngectomyKAC1Specification developeraccessdata.fda.gov
Tube, Tracheostomy (W/Wo Connector)BTO2Specification developeraccessdata.fda.gov
Unit, Cryosurgical, AccessoriesGEH2Repackager or relabeler, Specification developeraccessdata.fda.gov
Unit, Examining/Treatment, EntETF1Specification developeraccessdata.fda.gov
Varnish, CavityLBH2Complaint file establishment, Specification developeraccessdata.fda.gov
Warmer, Anesthetic TubeEFC1Specification developeraccessdata.fda.gov
Wheel, Polishing AgentEJQ1Specification developeraccessdata.fda.gov
Wrap, SterilizationFRG2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
March 3, 2026K260682Bond-PR™ Universal AdhesiveKLESubstantially EquivalentPremier Dental Products Companyaccessdata.fda.gov
November 7, 2025K253513MultiMatch Flow Chameleon AntiMicrobial CompositeEBFSubstantially EquivalentPremier Dental Products Companyaccessdata.fda.gov
December 6, 2022K223632Premier's MultiMatch Universal Chameleon Restorative CompositeEBFSubstantially EquivalentPremier Dental Products Companyaccessdata.fda.gov
February 27, 2019K180682AeroPro Cordless Prophy SystemEKXSubstantially EquivalentPremier Dental Company Productsaccessdata.fda.gov
October 18, 2016K161580Premier SealantEBCSubstantially EquivalentPremier Dental Company Productsaccessdata.fda.gov
March 3, 2016K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPEMSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
July 22, 2015K150601Zeramic Adhesive Resin CementEMASubstantially EquivalentPremier Dental Company Productsaccessdata.fda.gov
November 17, 2014K141839PREMIER ETCHKLESubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
November 26, 2013K132526KNIT-PAK+MVLSubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
August 26, 2013K131212PREMIER CERAMIC PRIMERKLESubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
October 6, 2010K102006CRYOMEGAGEHSubstantially EquivalentStc Consulting, LLCaccessdata.fda.gov
April 28, 2009K083695TRAXODENTMVLSubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
November 21, 2006K062683ENAMEL PRO VARNISHLBHSubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
November 21, 2006K062166ENAMEL PROEJRSubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
October 4, 2006K061998PREMIER SELF-ETCHING BOND ENHANCERKLESubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
September 6, 2005K051866PREMIER TEMPORARY CEMENTEMASubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
February 4, 2004K040098VARNISHAMERICALBHSubstantially EquivalentMedical Products Laboratories, Inc.accessdata.fda.gov
January 26, 2004K033309PREMIER IMPLANT CEMENT, MODEL 3001450EMASubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
November 18, 2003K031463MARINA MEDICAL SILICONE PESSARYHHWSubstantially EquivalentMarina Medical Instruments, Inc.accessdata.fda.gov
September 27, 2001K012160COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408EBFSubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
April 17, 2001K010195PREMIER ULTRASONIC SCALER AND INSERTSELCSubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
February 1, 2001K002042TRUCONE ROTATIONAL CONE BIOPSY INSTRUMENT, MODEL 231812 - 233018HGISubstantially EquivalentNew England Medical Corp.accessdata.fda.gov
November 13, 1997K972138CARR RIGID CONTAINER SYSTEMFRGSubstantially EquivalentCarr Metal Products, Inc.accessdata.fda.gov
June 17, 1997K970992PREMIER NITROSPRAY PLUS AND PREMIER NITROSPRAY LITE PLUSGEHSubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
January 30, 1995K945492HIGH TEMPERATURE CAUTERYGEISubstantially EquivalentAaron Medical Industriesaccessdata.fda.gov
January 26, 1994K933766HIGH-Q-BONDEBFSubstantially EquivalentSilmet U.S.A. Corp.accessdata.fda.gov
March 16, 1993K924823MICRODOSE SILANEELLSubstantially EquivalentUnicepaccessdata.fda.gov
October 13, 1992K923332ELECTROSURGICAL ELECTRODESGEISubstantially EquivalentPremier Dental Products Co.accessdata.fda.gov
February 13, 1990K896303BIOPSY PUNCHLRYSubstantially EquivalentPremier Medicalaccessdata.fda.gov
November 3, 1988K884015PREMIER DECANNULATION STOPPERBTOSubstantially EquivalentPremier Dentalaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
February 27, 202596394Class IIOngoingPremier Solo Diamond - Large Invented Cone; SKU: 807016C.The hardness not meeting the material specification and may cause the diamond bur to bend.accessdata.fda.gov
August 5, 200429920Not yet classifiedTerminatedTracheostomy Tubes, Jackson Original Stainless Steel, item number 1034300 size 00, item number 1034310 size 0, item number 1034311 size 1, item number 1034312 size 2, item number 1034313 size 3, item number 1034314 size foreign objects (polishing stones) in the tubesaccessdata.fda.gov
April 29, 200430366Not yet classifiedTerminatedNitrospray Plus (Item #1006060) with a 16 ounce fill capacity. Cryosurgical IntrstrumentCryogen can escape from canister through the seal ringaccessdata.fda.gov

Compare with other makers

Updated March 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.