FDA.reportPublic FDA data

Mini-Mono®

Primary DI
EFORM74012030051
Brand
Mini-Mono®
Company
Forestadent Bernhard Förster GmbH
Model
M740-1203-005
Device description
"Mini-Mono-Bracket Roth 'N' .018"" mand. 1+2 right+left "
Published
2019-10-02
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
EFORM74012030051PrimaryHIBCC0
EFORM7401203005001Unit 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4972314590info@forestadent.com

Regulatory Flags#

DUNS number
316074384
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EFOR4080105Track A1-408-01052025-07-04
EFOR4080106Track A1-408-01062025-07-04
EFOR4080108Track A1-408-01082025-07-04
EFOR4080110Track A1-408-01102025-07-04
EFOR4080115Track A1-408-01152025-07-04
EFOR4080120Track A1-408-01202025-07-04
EFOR4080220Track B1-408-02202025-07-04
EFOR4080515Track E1-408-05152025-07-04
EFOR4080520Track E1-408-05202025-07-04
EFOR4080530Track E1-408-05302025-07-04
EFOR5011845Special instrument for opening of BioQui-501-18452024-11-29
EFOR5011846Two pronged probe for BioQuick Brackets-501-18462024-11-30
EFOR4080610Track bleach-408-06102023-08-11
EFOR1101A23061OrthoEasy®1101A23062019-08-15
EFOR1101A23081OrthoEasy®1101A23082019-08-15
EFOR1101A23101OrthoEasy®1101A23102019-08-15
EFOR1201A23081OrthoEasy®1201A23082019-08-15
EFOR4080610001Track bleach-408-06102023-08-11
EFOR31210011N.A.-312-10012019-09-24
EFOR31210021N.A.-312-10022019-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190707192976Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192983Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707192990Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193003Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193010Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193027Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193034Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193041Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193058Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193065Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193072Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193089Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193096Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193102Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193119Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
00190707193126Aria® Expressions®Ortho Organizers, Inc.EJF2026-08-27
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00190746141515Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
00190746141522Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-09-03
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00190746174957Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175268Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175275Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175503Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26
00190746175510Stainless Steel BracketsAMERICAN ORTHODONTICS CORPORATIONEJF2021-08-26