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Data / Medical devices / United States / Preventive Technologies, Inc.

Preventive Technologies, Inc.: FDA-registered device maker in Indian Trail, NC, United States, 5 510(k) clearances

Preventive Technologies, Inc. is registered with the FDA (registration 1061053) in Indian Trail, NC, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 12, 2014. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
1061053
FEI number
1000511545
Address
4330C Matthews Indian Trail Rd, Indian Trail, NC, United States, 28079
Owner or operator
PREVENTIVE TECHNOLOGIES, INC. (9020368)
Roles
Manufacturer, Specification developer
First device listed
May 18, 1995
Registered through
2026
Brand names listed
ESA EXTENDED STRAIGHT, ESA® mate slow speed air driven motor, MAXMIN Prophylaxis Paste, NADA Pumice Paste, NEXT Prophylaxis Paste, PIVOT DISPOSABLE PROPHY ANGLE, VELLA 5% Sodium Fluoride Varnish with NUFLUOR and XYLITOL

Devices it lists

DeviceProduct codeClassRoleSource
Agent, Polishing, Abrasive, Oral CavityEJR1Manufacturer, Specification developeraccessdata.fda.gov
Cup, ProphylaxisEHK1Specification developeraccessdata.fda.gov
Handpiece, Air-Powered, DentalEFB1Specification developeraccessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, DentalEGS1Specification developeraccessdata.fda.gov
Varnish, CavityLBH2Manufactureraccessdata.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 12, 2014K140350VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOLLBHSubstantially EquivalentPreventive Technologies, Inc.accessdata.fda.gov
June 17, 2010K100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEEJRSubstantially EquivalentPreventive Technologies, Inc.accessdata.fda.gov
February 3, 2000K994024EXTENDED STRAIGHT ATTACHMENTEGSSubstantially EquivalentTeam Technologies, Inc.accessdata.fda.gov
May 2, 1995K951016DISPOSABLE PROPHYLAXIS ANGLEEHKSubstantially EquivalentPreventive Technologies, Inc.accessdata.fda.gov
November 15, 1978K781545AIR POWERED DENTAL HANDPIECEEFBSubstantially EquivalentPromident Mfg., Ltd.accessdata.fda.gov

Compare with other makers

Updated December 12, 2014. 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.