Data / Medical devices / India / Global Dent Aids Private Limited
Global Dent Aids Private Limited: FDA-registered device maker in NOIDA Uttar Pradesh, India, 1 510(k) clearance
Global Dent Aids Private Limited is registered with the FDA (registration 3002911411) in NOIDA Uttar Pradesh, India. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 15, 2013. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002911411
- Address
- 91, NSEZ, Gautam Buddha Nagar, NOIDA Uttar Pradesh, India, 201305
- Owner or operator
- GLOBAL DENT AIDS PVT LTD (9054924)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- January 30, 2003
- Registered through
- 2026
- Brand names listed
- DENTEK, DENTEMP, DenTek Gum Health Advanced Cleaning Kit, Interdental Brush, MANUAL#DENTAL, SLIMBRUSH, Sof-Grip
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Contract manufacturer | accessdata.fda.gov |
| Instrument, Hand, Calculus Removal | ELA | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Contract manufacturer | accessdata.fda.gov |
| Mouthguard, Over-The-Counter | OBR | U | Contract manufacturer | accessdata.fda.gov |
| Pick, Massaging | JET | 1 | Contract manufacturer | accessdata.fda.gov |
| Reliner, Denture, Over The Counter | EBP | 2 | Contract manufacturer | accessdata.fda.gov |
| Scraper, Tongue | LCN | 1 | Contract manufacturer, Exporter to the US | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Contract manufacturer, Repackager or relabeler | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 15, 2013 | K130186 | DENTEK EASY BRUSH WITH FLUORIDE | EFW | Substantially Equivalent | Den Tek Oral Care, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Toothbrush, Manual
- All makers of Reliner, Denture, Over The Counter
- All makers of Zinc Oxide Eugenol
- All makers of Instrument, Hand, Calculus Removal
- All makers of Pick, Massaging
- All makers of Mouthguard, Over-The-Counter
Updated July 15, 2013. 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.