Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013410675

FEI Number

3013410675

Entity Name

Ortho Pro Dent LLC

City/State/Country

Sarasota, FL, US

Establishment Address

1903 Northgate Blvd,Northogate Executive Center, suite 114, Sarasota, FL 34234, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Ortho Pro Dent LLC (Owner Number: 10053964)

Owner / Operator Contact Address

1903 Northgate Blvd , Northgate Executive center, suite 114, Sarasota, FL 34234, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K090567

PMA Number

N/A

All Registered Proprietary Names

Orthodontic adhesive light cure Orthodontic Adhesive - one step Mixing Adhesive bonding system Orthodontic adhesive Band cement acid etch and accessories Orthodontic Adhesive - No mix Devon Bond - light cure Max-Bond Orthodontic adhesive self bonding - light cure Max-Bond Adhesive light cure Devondent orthodontic Adhesive - light cure Orthodontic adhesive self bonding - light cure Devondent Orthodontic adhesive self bonding - light cure orthodontic band cleats orthodontic band and accessories ligual sheath promax bands Band Plain promax bands 1st Molar band , 2nd Molar band distal end cutter safety , distal end cutter long handle , dista end flush cutter angle plier, bird beak plier , three prong plier , jaraback plier , torquing plier male and female weingart plier , cinch back plier , Tweezer , bracket posioner , bracket holder , Tube holder Max Plier,Orthodontic Pliers , Dista end cutter , hard wire cutter , ligature pin cutters Dual Cure Luting Cement Zinc Phosphate Cement Light Cure Glass Ionomer Restorative Automix Dual Cure Luting Cement Zinc Oxide Eugenol Cement Non Eugenol Temporary Cement Polycarboxylate Cement Visible Light Cure Luting Surgical Cement Glass Ionomer Cement; Glass Ionomer Restorative Temporary Cement Zinc Oxide Eugenol Reinforced Material Visible Chemical Cure Pit and Fissure Visible Light Cure Pit and Fissure RC-CREAM Defon- Gel Root Canal Filling Material Orthodontic appliance and accessories ,elastomeric modules; Extraoral; Intraoral Ligature chain; Ligature ties; lip bumer tubing; Orthodontic elastomeric; rotation wedges; separators; thread Devon-Crown Trax-Plus Bracket Micro-Etched Roth slot 18 Trax-Plus Bracket Micro-Etched Roth slot 22 Self max-Selfligating Bracket System MBT slot 18 Trax-Plus Mini Twin Bracket MBT slot 18 Bracket accessories; Crimpabal hooks;Crimpabal stopers , lingual buttons; Metal bracket; Orthodontic brackets Trax-Plus Mini Twin Bracket Roth slot 22 Self max-Selfligating Bracket System Roth slot 18 Trax-Plus Mini Twin Bracket Roth slot 18 Self max-Selfligating Bracket System MBT slot 22 Trax-Plus Bracket Micro-Etched MBT slot 18 Trax-Plus Mini Twin Bracket MBT slot 22 Trax Bracket Micro-Etched Roth slot 18 Trax Bracket Micro-Etched Roth slot 22 Trax Bracket Micro-Etched MBT slot 18 Trax-Plus Bracket Micro-Etched MBT slot 22 Trax Bracket Micro-Etched MBT slot 22 Self max-Selfligating Bracket System Roth slot 22 alpha wire NiTi coated orthodontic wires alpha wire stainless steel wires coated TMA wires Orthodontic spring wires , Open coil , Closed coil alpha wire thermal activated wires alpha wire stainless steel wire alpha wire NiTi super elastic Orthodontic preformed ligature wires , Orthodontic Kobayshi wires Orthodontic stainless steel stranded wires Orthodontic reverse curved wires Devon-Core Devon-Core Dual Cure Core Automix Build Up Material DC Core Build Up Material Devon-Dent Chemical Core Build Up Material Devon-Dent Light Cure Core Build Up Material Core Build up material Devon- Gel Devon-Paste devonwhite in office bleaching system devonwhite bleaching , in office bleaching , devonwhite smile , Pro white smile, Pro white bleaching , dental bleaching Rannix - ceramic bracket with Metal slot system MBT slot 22 Translex - ceramic bracket system MBT slot 22 Translex - ceramic bracket system MBT slot 18 Orthodontic ceramic bracket. Glace- Crystal Sapphire Bracket System MBT slot 18 Orthodontic ceramic bracket with metal slot Rannix - ceramic bracket with Metal slot system MBT slot 18 Rannix - ceramic bracket with Metal slot system Roth slot 22 Glace- Crystal Sapphire Bracket System Roth slot 22 Rannix - ceramic bracket with Metal slot system Roth slot 18 Glace- Crystal Sapphire Bracket System MBT slot 22 Orthodontic Mono Crystalline Sapphire Bracket Glace- Crystal Sapphire Bracket System Roth slot 18 Translex - ceramic bracket system Roth slot 18 Translex - ceramic bracket system Roth slot 22

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYH	Adhesive, Bracket And Tooth Conditioner, Resin	Dental	Class 2	872.3750	2017-02-13
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2017-01-26
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2017-01-26
EMA	Cement, Dental	Dental	Class 2	872.3275	2018-04-17
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2018-04-17
EKQ	Preparer, Root Canal Endodontic	Dental	Class 1	872.4565	2018-04-17
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2017-03-22
ELZ	Crown, Preformed	Dental	Class 1	872.3330	2018-04-17
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2017-01-26
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2017-01-26
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2019-08-27
EIE	Dam, Rubber	Dental	Class 1	872.6300	2018-04-17
MAU	Eraser, Dental Stain	Dental	Class 1	872.6855	2025-02-10
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2021-01-07

Official Correspondent

EDWARD ELIAS

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ortho Pro Dent 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
K161684	Reliance Orthodontic Products, Inc.	Quantum LB	2016-10-06
K810210	Sci-Pharm, Inc.	MAGIC-TOUCH	1981-02-10
K875144	Reliance Orthodontic Products, Inc.	EXCEL FAST SET	1988-02-26
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09

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
1420089	RELIANCE ORTHODONTIC PRODUCTS, INC.	ITASCA, IL, US
2022039	SCIENTIFIC PHARMACEUTICALS, INC.	POMONA, CA, US
2126683	AMERICAN ORTHODONTICS	SHEBOYGAN, WI, US
3012187973	JERSEY DENTAL SUPPLIES	Lakewood, NJ, US
9612300	GC CORP.	ITABASHI-KU Tokyo, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013410675. Last updated year: 2026. Please use registration number 3013410675 when referencing this establishment in official correspondence.