M/S LEIXIR RESOURCES PVT. LTD

FDA Device Registration & Listing · GURUGRAM Haryana, IN · Registration 3014270094

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3014270094
FEI Number
3014270094
Entity Name
M/S LEIXIR RESOURCES PVT. LTD
City/State/Country
GURUGRAM Haryana, IN
Establishment Address
PLOT D -12/1 & 14 BLOCK D, INFOCITY II, SEC -33, GURUGRAM Haryana 122001, IN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
LEIXIR RESOURCES PRIVATE LIMITED (Owner Number: 10056722)
Owner / Operator Contact Address
101, VATIKA BUSINESS PARK,, TOWER-2, SOHNA ROAD, SECTOR-49,, GURGAON, IN-HR 122018, IN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Prosthesis, Orthodontic Denture, Partial Abutment, Implant, Dental, Endosseous- Biodenta Customized Abutment- Titanium Denture, cosmetic only Lucitone Digital Print Denture System Denture, Full Accessories, implant, dental , endosseous Restoration, PFM Restoration, resin Abutment, Implant, Dental, Endosseous- Biodenta customized abutment hybrid BRIDE RESTORATION CROWN RESIN

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NSR Prosthesis, Orthodontic Unknown Class N N/A 2019-07-08
NSK Dentures, Partial Unknown Class N N/A 2019-07-08
MQC Mouthguard, Prescription Unknown Class U N/A 2025-09-12
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-11-02
NXJ Denture, Cosmetic Only Unknown Class N N/A 2019-07-08
PZY Additively Manufactured, Preformed, Resin Denture Tooth Dental Class 2 872.3590 2025-09-10
EBG Crown And Bridge, Temporary, Resin Dental Class 2 872.3770 2025-09-10
EBI Resin, Denture, Relining, Repairing, Rebasing Dental Class 2 872.3760 2025-09-10
EBD Coating, Filling Material, Resin Dental Class 2 872.3310 2025-09-10
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2025-09-10
NSL Dentures, Full Unknown Class N N/A 2019-07-08
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2019-07-08
NSO Restoration, Porcelain-Fused-To-Metal Unknown Class N N/A 2019-07-08
NSM Restoration, Resin Unknown Class N N/A 2019-07-08
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-11-02
NSN Restoration, Resin, Crown And Bridge Unknown Class N N/A 2018-01-09

Official Correspondent

RAJIB PAL

US Agent Details

Lonnie Lee Email: llee@leixir.com Phone: (727) 4034775

Related Public Records

Same Entity

LEIXIR RESOURCES PRIVATE LIMITED
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
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18
K800400 Dentsply Intl. MAXUM DENTURE RESIN 1980-03-12
K033020 Cmp Industries, LLC IMPAK ACRYLIC REPAIR RESIN LIQUID 2003-12-19
K093019 Enamelite, LLC ENAMELITE ACRYSEAL SPRAY SEALANT 2009-12-22
K030585 Bisco, Inc. SCULPTING RESIN 2003-04-28

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014270094. Last updated year: 2026. Please use registration number 3014270094 when referencing this establishment in official correspondence.
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