Data / Medical devices / India / Sawbros Industries Pvt Ltd
Sawbros Industries Pvt Ltd: FDA-registered device maker in NOIDA Uttar Pradesh, India, 2 510(k) clearances
Sawbros Industries Pvt Ltd is registered with the FDA (registration 3008959450) in NOIDA Uttar Pradesh, India. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 28, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008959450
- Address
- A-68 Sector-2, NOIDA Uttar Pradesh, India, 201301
- Owner or operator
- SAWBROS INDUSTRIES PVT LTD (10035799)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- March 24, 2011
- Registered through
- 2026
- Brand names listed
- Aligner Chewy, Boone guage marker, Buccal Photographic Mirror, Contouring Kit and Refill, IPR Files, Lingual Retainer Wire, Lingual Retainer Wire Titanium, Lip-Retractor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Band, Elastic, Orthodontic | ECI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bracket, Plastic, Orthodontic | DYW | 2 | Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Manufacturer | accessdata.fda.gov |
| Headgear, Extraoral, Orthodontic | DZB | 2 | Manufacturer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Manufacturer | accessdata.fda.gov |
| Pusher, Band, Orthodontic | ECS | 1 | Manufacturer | accessdata.fda.gov |
| Retainer, Screw Expansion, Orthodontic | DYJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Manufacturer | accessdata.fda.gov |
| Strip, Polishing Agent | EHM | 1 | Manufacturer | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | 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 |
|---|---|---|---|---|---|---|
| August 28, 2017 | K162543 | Reverse Pull Adjustable Facemask | DZB | Substantially Equivalent | Sawbros Industries Pvt., Ltd. | accessdata.fda.gov |
| November 21, 1997 | K973776 | REFLECTIONS | DYW | Substantially Equivalent | Cdb Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Pusher, Band, Orthodontic
- All makers of Retainer, Screw Expansion, Orthodontic
- All makers of Gauge, Depth, Instrument, Dental
- All makers of Strip, Polishing Agent
- All makers of Retractor, All Types
- All makers of Headgear, Extraoral, Orthodontic
Updated August 28, 2017. 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.