Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004730002

FEI Number

3004730002

Entity Name

D B ORTHODONTICS LTD

City/State/Country

WEST YORKSHIRE England, GB

Establishment Address

RYEFIELD WAY, SILSDEN, KEIGHLEY, WEST YORKSHIRE England BD20 0EF, GB

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

DB Orthodontics Limited (Owner Number: 9065879)

Owner / Operator Contact Address

Unit 6, Ryefield Way, Silsden, Keighley, GB-NOTA BD20 0EF, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DB Orthodontics Bondable Buttons Airo Interdental Strips Nola Dry Field System Evolve Molar Bands DB Orthodontics Retractors Infinitas Orthodontic Mini Implant Sterile Ixion hand instruments DB Orthodontics hand instruments DB Orthodontic Instruments DB Orthodontics Spring DB Orthodontics Preformed Spring DB Orthodontics Coil Spring Evolve Orthodontic Brackets DB Orthodontics Mirror Evolve Flow Tube Evolve Tube Straight 8 Retainer Wire DB Orthodontics Archwire DB Orthodontics Wire Ligatures DB Orthodontics Archwire (Reel) Infinitas Orthodontic Mini Implant Non-Sterile IXION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2017-04-28
EHL	Point, Abrasive	Dental	Class 1	872.6010	2016-12-15
JEX	Plier, Orthodontic	Dental	Class 1	872.4565	2015-07-21
DYN	Mouthpiece, Saliva Ejector	Dental	Class 1	872.6640	2016-12-15
ECM	Band, Preformed, Orthodontic	Dental	Class 1	872.5410	2016-12-15
EIG	Retractor, All Types	Dental	Class 1	872.4565	2016-12-15
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2014-06-17
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2016-12-15
EJY	Pliers, Operative	Dental	Class 1	872.4565	2016-12-16
ECO	Spring, Orthodontic	Dental	Class 1	872.5410	2016-12-15
EJF	Bracket, Metal, Orthodontic	Dental	Class 1	872.5410	2016-12-15
EAX	Mirror, Mouth	Dental	Class 1	872.4565	2016-12-15
DZD	Tube, Orthodontic	Dental	Class 1	872.5410	2016-12-15
DZC	Wire, Orthodontic	Dental	Class 1	872.5410	2016-12-15
ECP	Instrument, Ligature Tucking, Orthodontic	Dental	Class 1	872.4565	2015-07-21
OAT	Implant, Endosseous, Orthodontic	Dental	Class 2	872.3640	2007-11-07
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2004-08-16

Official Correspondent

No official correspondent registered.

US Agent Details

Tim Law Business: Rounding Third LLC dba Smile Stream Solutions Email: tlaw@smilestreamsolutions.com Phone: (888) 2619933

Related Public Records

Same Entity

DB Orthodontics Limited

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
K781592	Henry Schein, Inc.	SURGICAL ASPIRATOR TIPS	1978-12-04
K110392	Psm Medical Solutions	PSM LOMAS / BENEFIT SCREWS	2011-12-14
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

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3004203816	MIS Implants Technologies Ltd.	BAR LEV INDUSTRIAL PARK Northern, IL
8043670	MKI DENTAL PRODUKT GMBH	Bockhorn Lower Saxony, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004730002. Last updated year: 2026. Please use registration number 3004730002 when referencing this establishment in official correspondence.