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Data / Medical devices / United States / Practicon, Inc.

Practicon, Inc.: FDA-registered device maker in Greenville, NC, United States, 6 510(k) clearances

Practicon, Inc. is registered with the FDA (registration 1051614) in Greenville, NC, United States. It lists 37 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 23, 2020. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Practicon, Inc.
FDA registration number
1051614
Address
1112 Sugg Pkwy., Greenville, NC, United States, 27834
Owner or operator
PRACTICON, INC. (1051614)
Roles
Manufacturer, Repackager or relabeler, Specification developer
First device listed
October 6, 2003
Registered through
2027
Brand names listed
ADDaSEAL Adhesive Face Mask Strips, ADDaSEAL RE Adhesive Face Mask Strips, Acu-Tip Electrosurgical Cauterizing Instrument, Angle-Ease, BFC UNIT DOSE SYRINGE, BFC3 Powered Impression Gun, Bite DX, Bliss Face Masks and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessories, Implant, Dental, EndosseousNDP1Manufactureraccessdata.fda.gov
Accessories, Retractor, DentalEIF1Specification developeraccessdata.fda.gov
Accessory, Surgical ApparelLYU1Specification developeraccessdata.fda.gov
Aligner, Bracket, OrthodonticECQ1Repackager or relabeleraccessdata.fda.gov
Band, Elastic, OrthodonticECI1Repackager or relabeleraccessdata.fda.gov
Dental Barriers And SleevesPEM2Repackager or relabeleraccessdata.fda.gov
Electrosurgical, Cutting & Coagulation & AccessoriesGEI2Repackager or relabeleraccessdata.fda.gov
Evacuator, Oral CavityEHZ1Repackager or relabeler, Specification developeraccessdata.fda.gov
Floss, DentalJES1Specification developeraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Repackager or relabeleraccessdata.fda.gov
Headlamp, Operating, Battery-OperatedHPP1Repackager or relabeleraccessdata.fda.gov
Holder, Film, X-RayEGZ1Specification developeraccessdata.fda.gov
Indicator, Physical/Chemical Sterilization ProcessJOJ2Repackager or relabeleraccessdata.fda.gov
Instrument, Cutting, OperativeEKD1Repackager or relabeleraccessdata.fda.gov
Instruments, Dental HandDZN1Repackager or relabeler, Specification developeraccessdata.fda.gov
Loupe, Diagnostic/SurgicalFSP1Repackager or relabeleraccessdata.fda.gov
Mask, SurgicalFXX2Specification developeraccessdata.fda.gov
Mirror, MouthEAX1Repackager or relabeleraccessdata.fda.gov
Needle, DentalDZM1Specification developeraccessdata.fda.gov
Pick, MassagingJET1Specification developeraccessdata.fda.gov
Protector, DentalBRW1Repackager or relabeler, Specification developeraccessdata.fda.gov
Retainer, MatrixJEP1Specification developeraccessdata.fda.gov
Retractor, All TypesEIG1Repackager or relabeleraccessdata.fda.gov
Scraper, TongueLCN1Specification developeraccessdata.fda.gov
Splint, Endodontic StabilizingELS2Manufactureraccessdata.fda.gov
Syringe, Periodontic, Endodontic, IrrigatingEIC1Specification developeraccessdata.fda.gov
Syringe, Restorative And Impression MaterialEID1Manufacturer, Repackager or relabeler, Specification developeraccessdata.fda.gov
Toothbrush, ManualEFW1Specification developeraccessdata.fda.gov
Toothbrush, PoweredJEQ1Repackager or relabeleraccessdata.fda.gov
Transilluminator, Battery-PoweredHJN1Specification developeraccessdata.fda.gov
Tray, Fluoride, DisposableKMT1Specification developeraccessdata.fda.gov
Tray, Impression, PreformedEHY1Repackager or relabeleraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Specification developeraccessdata.fda.gov
Unit, Operative Dental, AccessoriesNRD1Specification developeraccessdata.fda.gov
Unit, Syringe, Air And/Or WaterECB1Repackager or relabeleraccessdata.fda.gov
Wax, Dental, IntraoralEGD1Repackager or relabeleraccessdata.fda.gov
Wrap, SterilizationFRG2Repackager or relabeleraccessdata.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
December 23, 2020K201604Plasdent Disposable Barrier Sleeves and Barrier FilmPEMSubstantially EquivalentPlasdent Corporationaccessdata.fda.gov
January 24, 2019K182514Surgical Face MaskFXXSubstantially EquivalentXiantao Zhibo Non-Woven Products Co., Ltd.accessdata.fda.gov
April 28, 2017K162258Self Sealing Sterilization PouchesFRGSubstantially EquivalentTianchang Jiarui Packaging Material Co., Ltd.accessdata.fda.gov
March 3, 2016K151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmPEMSubstantially EquivalentPac-Dent International, Inc.accessdata.fda.gov
January 30, 1995K945765HIGH TEMPERATURE CAUTERYGEISubstantially EquivalentAaron Medical Industriesaccessdata.fda.gov
February 25, 1994K922673FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDINGELSSubstantially EquivalentGlasspan, Inc.accessdata.fda.gov

Compare with other makers

Updated December 23, 2020. 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.