Manufacturer registered with FDA
Sawbros Industries Pvt., Ltd.
NOIDA, India. Lists 11 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 11
- Brands and models
- 18
- 510(k) clearances
- 12017–2017
- Markets registered in
- 36 registrations outside the US
- Establishments
- 1India
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Sawbros Industries 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 | Sawbros Industries Pvt., Ltd. | 1 clearances | 2017–2017 | Below |
| European Union | EUDAMED | Manufacturer | Sawbros Industries Pvt. Ltd. | 4 | — | Pure Global AI |
| India | CDSCO | Registration holder | SAWBROS INDUSTRIES PVT LTD | 2 | 2023–2024 | 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 Sawbros Industries 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 |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Lister | Retainer Wire | 2015 |
| Orthodontic Plastic BracketDYW · Class 2 | Orthodontic brackets | Lister | Orthodontic Ceramic Buttons | 2019 |
| Orthodontic Extraoral HeadgearDZB · Class 2 | Retainers, expanders & headgear | Maker | Reverse Pull Adjustable Facemask | 2017 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Lingual Retainer WireLingual Retainer Wire TitaniumStainless Steel Wire | 2011 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Buccal Photographic MirrorOcclusion Photographic MirrorPhotographic Mirror | 2015 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | SEPARATOR, ORTHODONTIC | 2024 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | Aligner ChewyOrthodontic Positioner Seater | 2021 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | IPR FilesSeparatingSeparating Strips | 2011 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Lip-Retractor | 2013 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Boone guage marker | 2024 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Contouring Kit and Refill | 2018 |
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
Sawbros Industries 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: Cdb Corporation (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 21 Nov 1997 | K973776 | REFLECTIONS | Cdb Corporation | DYW Orthodontic Plastic Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SAWBROS INDUSTRIES PVT LTDFDA reg. 3008959450 | NOIDA Uttar Pradesh, India | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035799). 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.