Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008959450

FEI Number

3008959450

Entity Name

SAWBROS INDUSTRIES PVT LTD

City/State/Country

NOIDA Uttar Pradesh, IN

Establishment Address

A-68, SECTOR-2, NOIDA Uttar Pradesh 201301, IN

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

SAWBROS INDUSTRIES PVT LTD (Owner Number: 10035799)

Owner / Operator Contact Address

A-68, SECTOR-2, NOIDA, IN-UP 201301, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lip-Retractor Reverse Pull Adjustable Facemask Contouring Kit and Refill Photographic Mirror Occlusion Photographic Mirror Buccal Photographic Mirror Orthodontic Ceramic Buttons Separating Separating Strips IPR Files Lingual Retainer Wire Titanium Lingual Retainer Wire Stainless Steel Wire Retainer Wire Orthodontic Positioner Seater Aligner Chewy Boone guage marker SEPARATOR, ORTHODONTIC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIG	Retractor, All Types	Dental	Class 1	872.4565	2013-04-29
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2017-11-08
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2018-03-25
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2015-08-25
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2019-08-17
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2011-04-01
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2011-03-24
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2015-01-27
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2021-12-15
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2024-11-05
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2024-09-16

Official Correspondent

No official correspondent registered.

US Agent Details

Michael Sobotka Email: MSOBOTKA5@GMAIL.COM Phone: (917) 6203091

Related Public Records

Same Entity

SAWBROS INDUSTRIES PVT LTD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2012	Biomet Microfixation, Inc.	1	Biomet Microfixation outer packaging labeled in part:"REF: SP-2411*RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4MM, (3/16" INNER DIAMETER) NON LATEX ELASTICS LOT 307850DISTRIBUTED BY: BIOMET MICROFIXATION 1520 Tradeport Drive, Jacksonville, FL 32218 USA www.biometmicrofixation.com." Inner Vendor/Manufacturer Label labeled in part:"H4 Elastics 4mm (3/16") Heavy 4 oz. REF 11-102-04Manufactured for DENTSPLY GAC INTERNATIONAL DENTSPLY INTERNATIONAL, INC. Phone 631-419-1700 Fax 631-419-1599 355 Knickerbocker Avenue Bohemia NY 11716 USAMediMark Europe BP2332 F-38033 Grenoble Cedex 2. FranceLOT 82936-32 QTY:100 pk use by 2012-07 Made in USA ISSUED DATE 2009-04 GN**" Elastic bands used as elastomeric ties for ligation that facilitate treatment of fracture of the mandible and maxilla. They are commonly used with braces or arch bar wire.

Similar Registrations

Registration Number	Establishment Name	Location
3014647261	RETRACT EEZ, INC.	Largo, FL, US
3033892080	TALENT TECHNOLOGY MOULD CO., LIMITED	Shenzhen Guangdong, CN
1315756	Weco Manufacturing Group-Henrietta	Rochester, NY, US
3036269993	GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD	Nanning Guangxi, CN
3011585752	HANGZHOU HAIZHU MIM PRODUCTS CO., LTD	Hangzhou Zhejiang, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008959450. Last updated year: 2026. Please use registration number 3008959450 when referencing this establishment in official correspondence.