FDA.reportPublic FDA data

Legacy brkt

Primary DI
00889989018011
Brand
Legacy brkt
Company
ORMCO CORPORATION
Model
137-0137
Device description
U6L TBT BKT 2245 ANDREWS MT HK 5/-9/10
Published
2024-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00889989018011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989018011008899890180118899890180110889989018011

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18008541741ormcocustcare@ormco.com

Regulatory Flags#

DUNS number
154614119
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889989079494Tevdek II975-00502016-09-08
00889989079500Tevdek II975-00522016-09-08
00889989079517Tevdek II975-00542016-09-08
00889989079524Tevdek II975-00562016-09-08
00889989079531Tevdek II975-00632016-09-12
00889989079548Tevdek II975-00652016-09-12
00889989079555Tevdek II975-00672016-09-12
00889989073140Tubli-Seal003402016-09-08
00889989073157Tubli-Seal010812016-09-08
00889989074116Sealapex184322016-09-08
00889989074123Sealapex185982016-09-08
00889989074130Pulp Canal Sealer EWT247452016-09-08
00889989074147Pulp Canal Sealer EWT247462016-09-08
00889989074154Pulp Canal Sealer248732016-09-08
00889989074161Pulp Canal Sealer248742016-09-08
00889989074178Pulp Canal Sealer248752016-09-08
00889989074192Tubli-Seal EWT259032016-09-08
00889989074215Sealapex Xpress336392016-09-08
00889989074222Tubli-Seal Xpress336402016-09-08
00889989074239Tubli-Seal EWT Xpress336412016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456205389JMUJMU DENTAL, INCEJF2026-06-25
00840456205396JMUJMU DENTAL, INCEJF2026-06-25
00840456205402JMUJMU DENTAL, INCEJF2026-06-25
00840456205419JMUJMU DENTAL, INCEJF2026-06-25
00840456205914JMUJMU DENTAL, INCEJF2026-06-25
00840456205921JMUJMU DENTAL, INCEJF2026-06-25
00840456205938JMUJMU DENTAL, INCEJF2026-06-25
00840456205945JMUJMU DENTAL, INCEJF2026-06-25
00840456205952JMUJMU DENTAL, INCEJF2026-06-25
00840456205969JMUJMU DENTAL, INCEJF2026-06-25
00840456205976JMUJMU DENTAL, INCEJF2026-06-25
00840456205983JMUJMU DENTAL, INCEJF2026-06-25
00840456205990JMUJMU DENTAL, INCEJF2026-06-25
00840456206003JMUJMU DENTAL, INCEJF2026-06-25
00840456206010JMUJMU DENTAL, INCEJF2026-06-25
00840456206027JMUJMU DENTAL, INCEJF2026-06-25
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
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