Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005014825

FEI Number

3005014825

Entity Name

FORESTADENT USA

City/State/Country

Earth City, MO, US

Establishment Address

3451 Rider Trail South, Earth City, MO 63045, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

FORESTADENT USA (Owner Number: 9074785)

Owner / Operator Contact Address

3451, Earth City, MO 63045, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Smile Rx Alexander Sprint Hilgers Standard Edgewise Aspire Micro Sprint 3D Lingual Andrews Ricketts Mini Sprint Vertical Slot Glam BioQuick 2D Lingual RETAINER SCREW EXPANSION CLASP Classic Instruments Premier Instruments Expression Instruments Mini Ants Ricketts S Mini Sprint Roth N Offset Bi's Micro Sprint BioPassive Ricketts N Aspire Ceramic Standard Edgewise S Roth N Vertical slot Alexander S BioQuick Smile Rx Glam Aspire Plus Roth N Hilgers S 2D Plus Lingual 2D Lingual Standard Edgewise N MBT S2 Sprint QuicKlear CLAMP WIRE WIRE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2005-06-29
DYJ	Retainer, Screw Expansion, Orthodontic	Dental	Class 1	872.5410	2005-06-29
EHP	Clasp, Preformed	Dental	Class 1	872.3285	2005-06-29
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2005-06-29
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2005-06-29
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2005-06-29
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2005-06-29

Official Correspondent

DOUGLAS HURFORD

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FORESTADENT USA

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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16

Similar Registrations

Registration Number	Establishment Name	Location
3006707038	MYOFUNCTIONAL RESEARCH CORP. PTY. LTD.	HELENSVALE Queensland, AU
3032027578	Solventum Orthodontics Corporation	Monrovia, CA, US
1526352	SUMMIT ORTHODONTIC SERVICES, INC.	Schaumburg, IL, US
3014425175	Sharp Detail Orthodontic Laboratory S DE EL DE CV	Tijuana Baja California, MX
3015337428	GUANGZHOU CHEER-U MATERIAL TECHNOLOGY CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005014825. Last updated year: 2026. Please use registration number 3005014825 when referencing this establishment in official correspondence.