FDA.reportPublic FDA data

equilibrium®

Primary DI
J011790261020
Brand
equilibrium®
Company
DENTAURUM GmbH & Co.KG
Model
790-261-02
Device description
equilibrium® 2 Band bracket, - 11° Torque, + 7° Angulation for tooth 43
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011790261020PrimaryHIBCC0
J011790261021Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-3946info@dentaurum-us.com

Regulatory Flags#

DUNS number
315427286
Device count
10
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011250001400ceraMotion®250-001-402016-09-15
J011250002200ceraMotion®250-002-202016-09-15
J011250002400ceraMotion®250-002-402016-09-15
J011250003200ceraMotion®250-003-202016-09-15
J011250003400ceraMotion®250-003-402016-09-15
J011250004200ceraMotion®250-004-202016-09-15
J011250004400ceraMotion®250-004-402016-09-15
J011250005200ceraMotion®250-005-202016-09-15
J011250005400ceraMotion®250-005-402016-09-15
J011250006200ceraMotion®250-006-202016-09-15
J011250006400ceraMotion®250-006-402016-09-15
J011250018200ceraMotion®250-018-202016-09-15
J011250019200ceraMotion®250-019-202016-09-15
J011250021200ceraMotion®250-021-202016-09-15
J011250021400ceraMotion®250-021-402016-09-15
J011250022200ceraMotion®250-022-202016-09-15
J011250022400ceraMotion®250-022-402016-09-15
J011250023200ceraMotion®250-023-202016-09-15
J011250023400ceraMotion®250-023-402016-09-15
J011250024200ceraMotion®250-024-202016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013236601VECS Palate ExpanderAZURE MICRODYNAMICS, INC.EJF2026-06-05
00860013236618VECS Palate ExpanderAZURE MICRODYNAMICS, INC.EJF2026-06-05
00860013236625VECS Lab KitAZURE MICRODYNAMICS, INC.EJF2026-06-05
00860013236632VECS Activation KeyAZURE MICRODYNAMICS, INC.EJF2026-06-05
10190886271025G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271032G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271049G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271056G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271063G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
10190886271070G&H ORTHODONTICS ®G & H Wire Company, Inc.EJF2026-02-27
07908611216748METAL BRACKET U-CLIP PASSIVE ROTH 0,022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216755METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U1R (11) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216762METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U2R (12) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216779METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U3R (13) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216786METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U45R (14/15) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216793METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U1L (21) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216809METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U2L (22) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216816METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U3L (23) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216823METAL BRACKET U-CLIP PASSIVE ROTH 0.022 U45L (24/25) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216830METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L12RL (31/32/41/42) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216847METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L3L (33) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216854METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L4L (34) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216861METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L5L (35) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216878METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L3R (43) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216885METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L4R (44) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216892METAL BRACKET U-CLIP PASSIVE ROTH 0.022 L5R (45) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216908METAL BRACKET U-CLIP HYBRID ROTH 0.022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216939METAL BRACKET U-CLIP PASSIVE MBT 0,022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216946METAL BRACKET U-CLIP PASSIVE MBT 0.022 U1R (11) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12
07908611216953METAL BRACKET U-CLIP PASSIVE MBT 0.022 U2R (12) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-01-12