Manufacturer registered with FDA
Global Dent Aids Pvt. Ltd.
NOIDA, India. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 26 registrations outside the US
- Establishments
- 1India
Registered in 2 markets
Where regulators' registries name Global Dent Aids Pvt. Ltd. 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 | Global Dent Aids Pvt. Ltd. | 8 device types | — | Below |
| Colombia | INVIMA | Manufacturer | GLOBAL DENT AIDS PRIVATE LIMITED | 6 | — | 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 Global Dent Aids Pvt. Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Interdental BrushMANUAL#DENTALSLIMBRUSH | 2003 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | — | 2014 |
| Over the Counter Denture RelinerEBP · Class 2 | — | Maker | Sof-Grip | 2024 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Maker | DenTek Gum Health Advanced Cleaning Kit | 2013 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | DENTEMP | 2021 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | DENTEK | 2014 |
| Tongue ScraperLCN · Class 1 | — | Maker | — | 2013 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | — | 2017 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Global Dent Aids Pvt. Ltd. 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: Prestige Brands Holdings, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Jul 2013 | K130186 | DENTEK EASY BRUSH WITH FLUORIDE | Prestige Brands Holdings, Inc. | EFW Manual Toothbrush |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GLOBAL DENT AIDS PRIVATE LIMITEDFDA reg. 3002911411 | NOIDA Uttar Pradesh, India | Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9054924). 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.