Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015259864

FEI Number

3015259864

Entity Name

TANGENT ORTHODONTICS

City/State/Country

Franklin, IN, US

Establishment Address

2165 Earlywood Drive, Franklin, IN 46131, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Tangent Technologies LLC (Owner Number: 10059559)

Owner / Operator Contact Address

2165 Earlywood Drive, Franklin, IN 46131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Elastic Separators; Elastic Thread; Elastics; Energy Chain; Elastomeric Ligatures; Rotation Wedge Orthodontic Metal Brackets Patient Relief Wax Ceramic Orthodontic Brackets Orthodontic Wire and Archwires-Beta Titanium (Beta Ti); Nickel Titanium (NiTi) ; Stainless Steel (SS) ; Nickel Cobalt Bondable Button: Eruption Appliance, Crimpable Stop, Crimpable Hook, Orthodontic Buccal Tubes and Orthodontic Metal Tubes Orthodontic Springs- Nickel Titanium (NiTi) ; Stainless Steel (SS) : Nickel Cobalt

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECI	Band, Elastic, Orthodontic	Dental	Class 1	872.5410	2020-04-23
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2024-12-18
EGD	Wax, Dental, Intraoral	Dental	Class 1	872.6890	2024-04-04
NJM	Bracket, Ceramic, Orthodontic	Dental	Class 2	872.5470	2024-12-18
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2019-01-31
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2024-12-18
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2024-12-18
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2024-12-18

Official Correspondent

Brandon Bernacchi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Tangent Technologies 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
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13
K180404	3M Healthcare	3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System	2018-03-16
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
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
3022296393	FIRST DENTAL SUPPLIES LLC	Winter Garden, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015259864. Last updated year: 2026. Please use registration number 3015259864 when referencing this establishment in official correspondence.