Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009827000

FEI Number

3009827000

Entity Name

WHITE OAK ORTHODONTIC PRODUCTS

City/State/Country

Mount Joy, PA, US

Establishment Address

330 E Main St, Mount Joy, PA 17552, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

White Oak Orthodontic Products (Owner Number: 10042063)

Owner / Operator Contact Address

330 East Main Street, Mount Joy, PA 17552, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Infinity Innova Infinity Infinity Infinity Integrity Halo Ghost Infinity Novis Infinity Novis meridian vortex

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	2012-10-15
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2012-10-15
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2012-10-15
HTH	Protractor	Orthopedic	Class 1	888.4600	2012-10-16
ECT	Driver, Band, Orthodontic	Dental	Class 1	872.4565	2012-10-16
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2012-10-15
JES	Floss, Dental	Dental	Class 1	872.6390	2012-10-15
ECN	Clamp, Wire, Orthodontic	Dental	Class 1	872.5410	2012-10-15
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2012-10-15
HWT	Template	Orthopedic	Class 1	888.4800	2012-10-15
ECQ	Aligner, Bracket, Orthodontic	Dental	Class 1	872.4565	2012-10-15
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2016-10-17
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2012-10-16
ECS	Pusher, Band, Orthodontic	Dental	Class 1	872.4565	2012-10-15
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2012-10-15
DZB	Headgear, Extraoral, Orthodontic	Dental	Class 2	872.5500	2012-10-17
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2012-10-15

Official Correspondent

JAMES HESLOP

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

White Oak Orthodontic Products

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
K112640	Ormco Corp.	HYPERELASTIC WIRE	2011-11-16
K973236	Procter & Gamble Co.	CREST TOOTHBRUSH WITH MICROSHIELD	1998-03-11
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10
K894358	Ormco Corp.	LUMINA ORTHODONTIC BRACKET	1989-09-15
K925012	American Orthodontics	PLASTIC CHAIN	1993-09-13

Similar Registrations

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3031471645	FILIP ALBERT AMRAM JAWS GIDA SANAYI VE TICARET SIRKETI	Gaziemir Izmir, TR
9611458	Dentaurum GmbH & Co. KG	ISPRINGEN Baden-Wurttemberg, DE
1032347	BIOMET MICROFIXATION	Jacksonville, FL, US
8010414	PRODUITS DENTAIRES SA	VEVEY (SUISSE) Vaud, CH
3013508670	Ormco Corporation	Pomona, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009827000. Last updated year: 2026. Please use registration number 3009827000 when referencing this establishment in official correspondence.