FDA.reportPublic FDA data

BioMIM Mini Twin Brackets

Primary DI
00840273916550
Brand
BioMIM Mini Twin Brackets
Company
World Class Technology Corporation
Model
905.2023-100
Catalog number
905.2023-100
Device description
RO LR5 HK 22/-22/0/0 100PK
Published
2023-07-31
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
00840273916550PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840273916550008402739165508402739165500840273916550

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-752-0065info@oc-orthodontics.com

Regulatory Flags#

DUNS number
961810017
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
00840273922575APII960.00052026-02-25
00840273922582APII960.00012026-02-25
00840273922629Crimpable Attachments906.0007-20906.0007-202026-02-25
00840273922636Crimpable Attachments906.0008-202026-02-25
00840273919063Bands & Attachments34.30.120.0030534.30.120.003052024-03-14
00840273919070Bands & Attachments34.30.120.0031534.30.120.003152024-03-14
00840273919087Bands & Attachments34.30.120.0032534.30.120.003252024-03-14
00840273919094Bands & Attachments34.30.120.0033534.30.120.003352024-03-14
00840273919100Bands & Attachments34.30.120.0034534.30.120.003452024-03-14
00840273919117Bands & Attachments34.30.120.0035534.30.120.003552024-03-14
00840273919124Bands & Attachments34.30.120.0036534.30.120.003652024-03-14
00840273919131Bands & Attachments34.30.120.0037534.30.120.003752024-03-14
00840273919155Bands & Attachments34.30.120.0039534.30.120.003952024-03-14
00840273919162Bands & Attachments34.30.120.0040534.30.120.004052024-03-14
00840273918653Bands & Attachments33.30.210.0001333.30.210.000132024-02-29
00840273918660Bands & Attachments33.30.210.0001433.30.210.000142024-02-29
00840273918677Bands & Attachments33.30.210.0001533.30.210.000152024-02-29
00840273918684Bands & Attachments33.30.210.0001633.30.210.000162024-02-29
00840273918691Bands & Attachments33.30.210.0001733.30.210.000172024-02-29
00840273918707Bands & Attachments33.30.210.0001833.30.210.000182024-02-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898488904056METAL BRACKET ADVANCED ROTH 0.022 - U1R (11) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904063METAL BRACKET ADVANCED ROTH 0.022 - U2R (12) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904070METAL BRACKET ADVANCED ROTH 0.022 - U3R (13) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904087METAL BRACKET ADVANCED ROTH 0.022 - U45R (14,15) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904094METAL BRACKET ADVANCED ROTH 0.022 - U1L (21) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904100METAL BRACKET ADVANCED ROTH 0.022 - U2L (22) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904117METAL BRACKET ADVANCED ROTH 0.022 - U3L (23) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904124METAL BRACKET ADVANCED ROTH 0.022 - U45L (24,25) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904148METAL BRACKET ADVANCED ROTH 0.022 - L3L (33) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904155METAL BRACKET ADVANCED ROTH 0.022 - L4L (34) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904162METAL BRACKET ADVANCED ROTH 0.022 - L5L (35) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904179METAL BRACKET ADVANCED ROTH 0.022 - L3R (43) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904186METAL BRACKET ADVANCED ROTH 0.022 - L4R (44) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07898488904193METAL BRACKET ADVANCED ROTH 0.022 - L5R (45) - 100UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908470707678KIT LAUNCH - U-CLIPORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211286METAL BRACKET U-CLIP INTERACTIVE MBT 0.022 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211859METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - U1RL - (11/21) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211866METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - W/HOOK U3L/L3R (23/43) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611211873METAL BRACKET PREMIUM ELITE MBT 0.018 - 1 SET (6X6)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611212689METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611212696METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - 1 SET (6X6)ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213525METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - (12/22/31/32/41/42) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213570METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - W/HOOK U3R/L3L (13/33) - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611213921METAL BRACKET PREMIUM ELITE EDGEWISE 0.018 - U3RL/U45RL/L345L/L345R - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
07908611215253METAL BRACKET U-CLIP DUAL PLUS – 1 SETORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAEJF2026-05-26
00190746191602Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191619Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191626Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191633Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191640Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23