Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1061053

FEI Number

1000511545

Entity Name

PREVENTIVE TECHNOLOGIES, INC.

City/State/Country

Indian Trail, NC, US

Establishment Address

4330C Matthews Indian Trail Rd, Indian Trail, NC 28079, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

PREVENTIVE TECHNOLOGIES, INC. (Owner Number: 9020368)

Owner / Operator Contact Address

4330-C Matthews-Indian Trail Road, --, Indian Trail, NC 28079, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100539

PMA Number

N/A

All Registered Proprietary Names

VELLA 5% Sodium Fluoride Varnish with NUFLUOR and XYLITOL ESA® mate slow speed air driven motor PIVOT DISPOSABLE PROPHY ANGLE MAXMIN Prophylaxis Paste NADA Pumice Paste NEXT Prophylaxis Paste

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2015-01-02
EFB	Handpiece, Air-Powered, Dental	Dental	Class 1	872.4200	2017-10-05
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	1995-05-18
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2010-12-27

Official Correspondent

AL KING

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PREVENTIVE TECHNOLOGIES, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033295	Novamin Technology, Inc.	BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN	2003-10-28
K212910	Shenzhen Carejoy Technology Co., Ltd.	Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece	2022-11-17
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1061053. Last updated year: 2026. Please use registration number 1061053 when referencing this establishment in official correspondence.