Product Code: EJF FDA class 1 21 CFR 872.5410

Bracket, Metal, Orthodontic

Dental

The Metal Orthodontic Bracket is a small metal attachment bonded to the tooth surface as part of a fixed orthodontic appliance, designed to receive and retain the archwire that applies forces to move teeth into the desired position. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJF, regulated under 21 CFR 872.5410 in the Dental (DE) specialty.

View on FDA

510(k)s

103

FEI Numbers

160

Registration Numbers

160

Unique Applicants

Years Active

Research product code EJF in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: EJF
Device Class: FDA class 1
Regulation Number: 872.5410
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 103 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K994357	BITEM LOCK, MODELS SW006, SW012	Mar 14, 2000	Substantially Equivalent	Thermoelastic Technologies, Inc.
K932825	MICROARCH GOLD BRACKET	May 09, 1994	Substantially Equivalent	Gac Intl., Inc.
K933501	ALASTIK	Apr 28, 1994	Substantially Equivalent	Unitek Corp.
K923372	MEMORY WIRE	Apr 22, 1994	Substantially Equivalent	Althan, Inc.
K933080	ORTHOTECH DURA-GOLD BARCKETS	Mar 23, 1994	Substantially Equivalent	Orthotech
K935139	FASCINATION CERAMIC BRACKET	Feb 04, 1994	Substantially Equivalent	Dentauraum, Inc.
K936244	REGENCY BRACKET	Feb 02, 1994	Substantially Equivalent	Mid-American Dental Specialties, Inc.
K934881	REFLECTIONS	Feb 01, 1994	Substantially Equivalent	Cdb Corp.
K935122	DENTAURUM METAL BRACKETS	Jan 31, 1994	Substantially Equivalent	Dentauraum, Inc.
K926427	LARIAT PALATE EXPANDER	Jan 26, 1994	Substantially Equivalent	Easy Access Orthodontics, Inc.
K925028	FORESTADENT ORTHODONTIC BANDS	Jan 26, 1994	Substantially Equivalent	Forestadent
K930881	CHANNEL-EDGE BRACKET SYSTEM	Jan 21, 1994	Substantially Equivalent	Dualtek, Inc.
K933758	REGENCY PLUS BRACKET	Jan 18, 1994	Substantially Equivalent	Mid-American Dental Specialties, Inc.
K922806	ORMCO SPORTSGUARD	Oct 20, 1993	Substantially Equivalent	Ormco Corp.
K932025	ION-IMPLANTED NEO SENTALLOY	Sep 13, 1993	Substantially Equivalent	Gac Intl., Inc.
K925012	PLASTIC CHAIN	Sep 13, 1993	Substantially Equivalent	American Orthodontics
K923218	NITANIUM PALATAL EXPANDER	Sep 13, 1993	Substantially Equivalent	Ortho Organizers, Inc.
K931663	NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL	Jul 08, 1993	Substantially Equivalent	Ortho Organizers, Inc.
K930452	SOLO TIES	Jul 08, 1993	Substantially Equivalent	Zulaf, Inc.
K924971	FORESTADENT BRACKETS	May 27, 1993	Substantially Equivalent	Forestadent Bernhard Forster GmbH
K923405	THE HERBST APPLIANCE	May 05, 1993	Substantially Equivalent	Ormco Corp.
K923440	APEX DIRECT BONDED BRACKETS	Mar 31, 1993	Substantially Equivalent	Apex Orthodontics, Inc.
K923709	MEMORY WIRE	Feb 02, 1993	Substantially Equivalent	Wire Products
K923261	ORTHODONTIC METAL BRACKET	Dec 03, 1992	Substantially Equivalent	American Orthodontics
K923432	GERMAN MINI DYNALOCK	Oct 30, 1992	Substantially Equivalent	Unitek Corp.
K923029	ORTHODONTIC STAINLESS STEEL BRACKET	Sep 28, 1992	Substantially Equivalent	Gac Intl., Inc.
K923124	GLENROE GOLDEN ORTHODONTIC BRACKET	Aug 27, 1992	Substantially Equivalent	Glenroe
K922499	REFLECTIONS - CERAMIC DENTAL BRACKET	Jul 30, 1992	Substantially Equivalent	Cdb Corp.
K920645	ORTHODONTIC ELASTICS BANDS	Jul 28, 1992	Substantially Equivalent	Masel Industries, Inc.
K914003	MIDAS BRACKET	Dec 16, 1991	Substantially Equivalent	Gold'N Braces, Inc.
K913913	REFURBISHED ORTHODONTIC APPLIANCES	Nov 27, 1991	Substantially Equivalent	Ortho-Cycle Co.
K914616	KLEER(TM) ORTHODONTIC BRACKET	Nov 20, 1991	Substantially Equivalent	Ormco Corp.
K911231	ORTHODONTIC WIRE	Oct 08, 1991	Substantially Equivalent	Masel Industries, Inc.
K912171	PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE	Aug 13, 1991	Substantially Equivalent	Jack James
K910288	NONSTAINING ALASTIKS	Mar 29, 1991	Substantially Equivalent	Unitek Corp.
K903498	RETAINER, SCREW EXPANSION ORTHODONTIC	Mar 12, 1991	Substantially Equivalent	Masel Industries, Inc.
K902809	BRACKET, METAL, ORTHODOTNIC	Dec 07, 1990	Substantially Equivalent	Masel Industries, Inc.
K904092	LANCER ORIGINAL, SIERRA, GENERAL PURPOSE	Nov 09, 1990	Substantially Equivalent	Lancer Orthodontics, Inc.
K904093	BUCCAL TUBE, BUCCAL ATTACHMENT	Nov 07, 1990	Substantially Equivalent	Lancer Orthodontics, Inc.
K904091	TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO	Nov 05, 1990	Substantially Equivalent	Lancer Orthodontics, Inc.
K904094	C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE	Nov 02, 1990	Substantially Equivalent	Lancer Orthodontics, Inc.
K904089	PERMA MESH	Nov 02, 1990	Substantially Equivalent	Lancer Orthodontics, Inc.
K903214	OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS	Sep 05, 1990	Substantially Equivalent	Medical Fittings, Inc.
K902844	NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN	Sep 05, 1990	Substantially Equivalent	Progressive Dental Supply
K902390	AURA CERAMIC DENTAL APPLIANCE	Aug 13, 1990	Substantially Equivalent	Progressive Technology, Inc.
K901896	ENDOMETRIAL SAMPLER	Aug 13, 1990	Substantially Equivalent	Kirwan Surgical Products, Inc.
K900678	THE MYOLOC SYSTEM	Aug 13, 1990	Substantially Equivalent	Winder Research, Inc.
K902064	MODIFIED UNI-STICK PLASTIC LIGATURE	Aug 06, 1990	Substantially Equivalent	American Orthodontics
K902050	BIOLASTIC SUPER ELASTIC ARCHES	Aug 03, 1990	Substantially Equivalent	Rmo, Inc.
K900471	FIBERBRAID(TM) BONDED RETAINER	Aug 02, 1990	Substantially Equivalent	Uthoff Dental Mfg.
K901957	MUSTANG, C.A.T.	Jul 30, 1990	Substantially Equivalent	Lancer Orthodontics, Inc.
K900488	MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE	Jun 01, 1990	Substantially Equivalent	American Orthodontics
K900824	FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM)	May 22, 1990	Substantially Equivalent	Midwest Orthodontic Mfg.
K901024	STAINLESS STEEL DENTAL WIRES AND CLASPS	Apr 25, 1990	Substantially Equivalent	Ivoclar North America, Inc.
K900578	SPORTS PACK ELASTICS	Apr 10, 1990	Substantially Equivalent	Lancer Orthodontics, Inc.
K895854	ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE)	Apr 09, 1990	Substantially Equivalent	Acme-Monaco Corp.
K900184	LINGUAL SHEATH	Apr 02, 1990	Substantially Equivalent	Ormco Corp.
K895483	ACME COATED ORTHODONTIC ARCHWIRE	Jan 29, 1990	Substantially Equivalent	Acme-Monaco Corp.
K891331	UNI-STICK PLASTIC LIGATURES	Oct 16, 1989	Substantially Equivalent	American Orthodontics
K893482	KORN MANDIBULAR ADVANCER	Oct 12, 1989	Substantially Equivalent	American Orthodontics
K894781	OPTIFLEX	Sep 15, 1989	Substantially Equivalent	Ormco Corp.
K894358	LUMINA ORTHODONTIC BRACKET	Sep 15, 1989	Substantially Equivalent	Ormco Corp.
K893655	KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK	Aug 23, 1989	Substantially Equivalent	American Orthodontics
K893555	X-RING AND SPEED STIX PLASTIC LIGATURES	Jul 14, 1989	Substantially Equivalent	American Orthodontics
K893550	PLASTIC FORCE MODULE	Jul 14, 1989	Substantially Equivalent	American Orthodontics
K893484	MULTIPHASE ORTHODONTIC WIRE	Jul 14, 1989	Substantially Equivalent	American Orthodontics
K893483	BONDABLE RETAINER AND SPACE MAINTAINER	Jul 14, 1989	Substantially Equivalent	American Orthodontics
K891982	J1 ATTACHMENT (ORTHODONTIC APPLIANCE)	Jul 14, 1989	Substantially Equivalent	T.M.K. Dental Products
K893654	MEMORY CHAIN	Jun 23, 1989	Substantially Equivalent	American Orthodontics
K893549	X-RING SEPARATORS	Jun 23, 1989	Substantially Equivalent	American Orthodontics
K893542	DIASTEMA CLOSING KIT	Jun 23, 1989	Substantially Equivalent	American Orthodontics
K892419	NPG 2 BASE METAL ALLOY	Jun 16, 1989	Substantially Equivalent	Aalba Dent, Inc.
K892704	GEM II ORTHODONTIC BRACKET	Jun 12, 1989	Substantially Equivalent	Ormco Corp.
K891775	MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES	May 11, 1989	Substantially Equivalent	American Orthodontics
K891599	FILAFLEX ORTHODONTIC WIRE	May 02, 1989	Substantially Equivalent	American Orthodontics
K890536	JASPER JUMPER KIT	May 01, 1989	Substantially Equivalent	American Orthodontics
K890656	LIP BUMPER	Apr 17, 1989	Substantially Equivalent	American Orthodontics
K891484	ORTHODONTIC WRAP-AROUND HAWLEY RETAINER	Apr 14, 1989	Substantially Equivalent	American Orthodontics
K891592	ORTHODONTIC ARCH AND SURGICAL HOOKS	Apr 07, 1989	Substantially Equivalent	American Orthodontics
K890581	THE CLARK LIP SHIELD	Mar 17, 1989	Substantially Equivalent	American Orthodontics
K890145	20/20 ORTHODONTIC CERAMIC BRACKET	Mar 13, 1989	Substantially Equivalent	American Orthodontics
K890529	ALASTIGARD	Mar 09, 1989	Substantially Equivalent	Unitek Corp.
K885086	TIN COATED NITI ORTHODONTIC ARCH WIRES	Jan 10, 1989	Substantially Equivalent	Flexmedics
K883120	FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE	Nov 14, 1988	Substantially Equivalent	Flexmedics
K881789	MINILINE BRACKET	Jun 01, 1988	Substantially Equivalent	Alexotek Co.
K874396	OCO PREPARATIONS	May 18, 1988	Substantially Equivalent	Williams Importing Company, Inc.
K881274	CENTER BEND ARCH WIRES	Apr 12, 1988	Substantially Equivalent	Flexmedics
K881233	STRAIGHT LENGTH ARCH WIRES	Apr 12, 1988	Substantially Equivalent	Flexmedics
K880882	REVERSE CURVE ARCHWIRE	Apr 11, 1988	Substantially Equivalent	Flexmedics
K881163	RECTANGULAR NITINOL ARCH WIRE	Apr 07, 1988	Substantially Equivalent	Flexmedics
K874226	STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET	Dec 29, 1987	Substantially Equivalent	Advanced Orthodontics Systems, Inc.
K873649	FLEX GOLD	Oct 05, 1987	Substantially Equivalent	Flexmedics
K870536	GEM ORTHODONTIC BRACKET	Feb 19, 1987	Substantially Equivalent	Ormco Corp.
K852179	CERAMIC ORTHODONIT APPLIANCE	Aug 20, 1985	Substantially Equivalent	Gac Intl., Inc.
K852800	A-COMPANY SELF-LIGATING APPLIANCE	Jul 31, 1985	Substantially Equivalent	A Company, Inc.
K844067	VANISH ORTHODONTIC BRACKET	Nov 23, 1984	Substantially Equivalent	A Company, Inc.
K843143	STABILIZING RETAINER	Sep 27, 1984	Substantially Equivalent	Dental Advancements, Inc.
K834272	ALEXOLOK BRACKET	Feb 03, 1984	Substantially Equivalent	Alexotek Co.
K812300	LINGUAL BRACKET	Sep 21, 1981	Substantially Equivalent	American Ormco
K803316	ORTHODONTIC BRACKET	Jan 14, 1981	Substantially Equivalent	Orec Corp.
K801809	ORTHODONTIC BRACKET/SPEED/HANSON SPEED	Aug 13, 1980	Substantially Equivalent	Strite Industries , Ltd.
K780170	ORTHODONTIC BRACKET PADS	Mar 15, 1978	Substantially Equivalent	Rocky Mountain Orthodontics, Inc.
K771774	NEW BASE FOR ORTHODONTIC APPLIANCES	Sep 30, 1977	Substantially Equivalent	Gac Intl., Inc.