Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008882689

FEI Number

3008882689

Entity Name

Xplora USA LLC

City/State/Country

Carrollton, TX, US

Establishment Address

1501 Randolph St, Ste K16, Carrollton, TX 75006, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Xplora USA LLC (Owner Number: 10089697)

Owner / Operator Contact Address

1501 Randolph St, Ste K16, Carrollton, TX 75006, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K071688

PMA Number

N/A

All Registered Proprietary Names

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Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2024-01-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2024-01-08
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2024-01-08
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2024-01-08
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2024-01-08
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2024-01-08
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2024-01-08
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2024-01-08
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-01-08
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2024-01-08
ELK	Teeth, Artificial, Backing And Facing	Dental	Class 1	872.3910	2024-02-28
EIF	Accessories, Retractor, Dental	Dental	Class 1	872.4565	2024-01-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2024-01-08
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2024-01-08
QJJ	Indirect Bonding Tray	Dental	Class 1	872.5410	2024-01-08
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2024-01-08
DYW	Bracket, Plastic, Orthodontic	Dental	Class 2	872.5470	2024-01-08
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2024-01-08
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2024-01-08
EBZ	Activator, Ultraviolet, For Polymerization	Dental	Class 2	872.6070	2024-01-08
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2024-01-08
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2024-01-08
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2024-01-08
NXC	Aligner, Sequential	Dental	Class 2	872.5470	2023-12-29
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2024-01-08

Official Correspondent

Bruce Page

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Xplora USA LLC

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
K020499	Jeneric/Pentron, Inc.	BOND-3 ADHESIVE	2002-04-22
K801093	Dentsply Intl.	PRISMA-BOND	1980-05-20
K061981	Apex Dental Materials, Inc.	SURPASS	2006-07-31
K110302	3M Espe AG	ADHESIVE EXL-759	2011-05-19
K071131	3M Espe AG Dental Products	UNO	2007-07-25

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.
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-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008882689. Last updated year: 2026. Please use registration number 3008882689 when referencing this establishment in official correspondence.