Manufacturer registered with FDA
Preventive Technologies, Inc.
Indian Trail, NC, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 7
- 510(k) clearances
- 31995–2014
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Preventive Technologies, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Preventive Technologies, Inc. | 3 clearances | 1995–2014 | Below |
| Taiwan | TFDA | Manufacturer | PREVENTIVE TECHNOLOGIES INC. | 1 | 2015–2015 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Preventive Technologies, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | ESA® mate slow speed air driven motor | 2017 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | ESA EXTENDED STRAIGHT | 2006 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | PIVOT DISPOSABLE PROPHY ANGLE | 1995 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | MAXMIN Prophylaxis PasteNADA Pumice PasteNEXT Prophylaxis Paste | 2010 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | VELLA 5% Sodium Fluoride Varnish with NUFLUOR and XYLITOL | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Preventive Technologies, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Dec 2014 | K140350 | VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL | LBH Cavity Varnish |
| 17 Jun 2010 | K100539 | PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE | EJR Oral Cavity Abrasive Polishing Agent |
| 2 May 1995 | K951016 | DISPOSABLE PROPHYLAXIS ANGLE | EHK Prophylaxis Cup |
Some of these clearances are listed with FDA today by another company: Cordica Medical (Formally Team Technologies, Inc) (1).
Also lists devices cleared under other names
Preventive Technologies, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Team Technologies, Inc. (1), Promident Mfg., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 3 Feb 2000 | K994024 | EXTENDED STRAIGHT ATTACHMENT | Team Technologies, Inc. | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 15 Nov 1978 | K781545 | AIR POWERED DENTAL HANDPIECE | Promident Mfg., Ltd. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PREVENTIVE TECHNOLOGIES, INC.FDA reg. 1061053 | Indian Trail, NC, United States | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9020368). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.