Product code EJF

Device name: Bracket, Metal, Orthodontic
Medical specialty: Dental
Device class: 1
Regulation number: 872.5410
Review panel: DE
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K994357	BITEM LOCK, MODELS SW006, SW012	Thermoelastic Technologies, Inc.	2000-03-14
K932825	MICROARCH GOLD BRACKET	Gac Intl., Inc.	1994-05-09
K933501	ALASTIK	Unitek Corp.	1994-04-28
K923372	MEMORY WIRE	Althan, Inc.	1994-04-22
K933080	ORTHOTECH DURA-GOLD BARCKETS	Orthotech	1994-03-23
K935139	FASCINATION CERAMIC BRACKET	Dentauraum, Inc.	1994-02-04
K936244	REGENCY BRACKET	Mid-American Dental Specialties, Inc.	1994-02-02
K934881	REFLECTIONS	Cdb Corp.	1994-02-01
K935122	DENTAURUM METAL BRACKETS	Dentauraum, Inc.	1994-01-31
K926427	LARIAT PALATE EXPANDER	Easy Access Orthodontics, Inc.	1994-01-26
K925028	FORESTADENT ORTHODONTIC BANDS	Forestadent	1994-01-26
K930881	CHANNEL-EDGE BRACKET SYSTEM	Dualtek, Inc.	1994-01-21
K933758	REGENCY PLUS BRACKET	Mid-American Dental Specialties, Inc.	1994-01-18
K922806	ORMCO SPORTSGUARD	Ormco Corp.	1993-10-20
K932025	ION-IMPLANTED NEO SENTALLOY	Gac Intl., Inc.	1993-09-13
K925012	PLASTIC CHAIN	American Orthodontics	1993-09-13
K923218	NITANIUM PALATAL EXPANDER	Ortho Organizers, Inc.	1993-09-13
K931663	NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL	Ortho Organizers, Inc.	1993-07-08
K930452	SOLO TIES	Zulaf, Inc.	1993-07-08
K924971	FORESTADENT BRACKETS	Forestadent Bernhard Forster GmbH	1993-05-27
K923405	THE HERBST APPLIANCE	Ormco Corp.	1993-05-05
K923440	APEX DIRECT BONDED BRACKETS	Apex Orthodontics, Inc.	1993-03-31
K923709	MEMORY WIRE	Wire Products	1993-02-02
K923261	ORTHODONTIC METAL BRACKET	American Orthodontics	1992-12-03
K923432	GERMAN MINI DYNALOCK	Unitek Corp.	1992-10-30
K923029	ORTHODONTIC STAINLESS STEEL BRACKET	Gac Intl., Inc.	1992-09-28
K923124	GLENROE GOLDEN ORTHODONTIC BRACKET	Glenroe	1992-08-27
K922499	REFLECTIONS - CERAMIC DENTAL BRACKET	Cdb Corp.	1992-07-30
K920645	ORTHODONTIC ELASTICS BANDS	Masel Industries, Inc.	1992-07-28
K914003	MIDAS BRACKET	Gold'N Braces, Inc.	1991-12-16

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
07908611216847	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L3L (33) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611217004	METAL BRACKET U-CLIP PASSIVE MBT 0.022 U3L (23) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216991	METAL BRACKET U-CLIP PASSIVE MBT 0.022 U2L (22) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216984	METAL BRACKET U-CLIP PASSIVE MBT 0.022 U1L (21) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216977	METAL BRACKET U-CLIP PASSIVE MBT 0.022 U45R (14/15) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216960	METAL BRACKET U-CLIP PASSIVE MBT 0.022 U3R (13) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216953	METAL BRACKET U-CLIP PASSIVE MBT 0.022 U2R (12) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216946	METAL BRACKET U-CLIP PASSIVE MBT 0.022 U1R (11) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216939	METAL BRACKET U-CLIP PASSIVE MBT 0,022 - 1 SET	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216908	METAL BRACKET U-CLIP HYBRID ROTH 0.022 - 1 SET	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216892	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L5R (45) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216885	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L4R (44) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216878	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L3R (43) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216861	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L5L (35) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216854	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L4L (34) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216830	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L12RL (31/32/41/42) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216823	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U45L (24/25) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216816	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U3L (23) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216809	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U2L (22) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216793	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U1L (21) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216786	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U45R (14/15) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216779	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U3R (13) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216762	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U2R (12) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216755	METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U1R (11) - 5UN	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611216748	METAL BRACKET U-CLIP PASSIVE ROTH 0,022 - 1 SET	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2026-01-12
07908611211170	PREMIUM ELITE KIT MBT 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2025-04-07
07908611211163	PREMIUM ELITE KIT ROTH 0.022 – 1 SET + 4 TUBES + 1 PAIR OF ARCHES + 1 MODULAR	ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA	2025-04-07
07895742160814	Morelli	Dental Morelli Ltda	2021-04-30
07895742160838	Morelli	Dental Morelli Ltda	2021-04-30
07895742160821	Morelli	Dental Morelli Ltda	2021-04-30

Product code EJF

Related 510(k) Records#

Related GUDID Devices#