Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3022296393

FEI Number

3022296393

Entity Name

FIRST DENTAL SUPPLIES LLC

City/State/Country

Winter Garden, FL, US

Establishment Address

17808 Sharp Pummelo Aly, Winter Garden, FL 34787, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

First Dental Supplies LLC (Owner Number: 10084802)

Owner / Operator Contact Address

17808 Sharp Pummelo Aly, Winter Garden, FL 34787, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Band, Elastic, Orthodontic IMPLANT, ENDOSSEOUS, ORTHODONTIC Instruments, Dental Hand PUSHER, BAND, ORTHODONTIC Aligner, Bracket, Orthodontic RETRACTOR, ALL TYPES BUR, DENTAL STRIP, POLISHING AGENT Spring, Orthodontic Wire, Orthodontic Instrument, Ligature Tucking, Orthodontic MATERIAL, TOOTH SHADE, RESIN FACEBOW Bracket, Metal, Orthodontic WAX, DENTAL, INTRAORAL toothbrush, manual Clamp, Wire, Orthodontic SCRAPER, TONGUE BRACKET, CERAMIC, ORTHODONTIC ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN TRAY, IMPRESSION, PREFORMED Plier, Orthodontic Tube, Orthodontic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2022-04-01
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2025-01-10
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2022-04-01
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2025-11-18
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2022-04-01
EIG	Retractor, All Types	Dental	Class 1	872.4565	2025-01-10
EJL	Bur, Dental	Dental	Class 1	872.3240	2025-11-18
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2025-01-10
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2022-04-01
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2022-04-01
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2022-04-01
EMA	Cement, Dental	Dental	Class 2	872.3275	2025-01-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-01-10
KCR	Facebow	Dental	Class 1	872.3220	2025-01-10
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2022-04-01
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2025-01-10
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2025-11-18
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2022-04-01
LCN	Scraper, Tongue	Dental	Class 1	872.6855	2025-01-10
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2025-01-10
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2025-01-10
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2025-01-10
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2025-11-18
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2022-04-01
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2022-04-01

Official Correspondent

Diego Aguiar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

First Dental Supplies 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
K110392	Psm Medical Solutions	PSM LOMAS / BENEFIT SCREWS	2011-12-14
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31

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-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.).

Similar Registrations

Registration Number	Establishment Name	Location
3008005217	US ORTHODONTIC PRODUCTS	Norwalk, CA, US
3009491780	Phoenix Orthodontics Inc	Marietta, GA, US
1833132	G & H Wire Company	Franklin, IN, US
9611458	Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, DE
3008882689	Xplora USA LLC	Carrollton, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022296393. Last updated year: 2026. Please use registration number 3022296393 when referencing this establishment in official correspondence.