FDA.report

Mini-Mono®

Primary DI
EFOR77523011
Brand
Mini-Mono®
Company
Forestadent Bernhard Förster GmbH
Model
-775-2301
Device description
High-Tech-Brackets Alexander 'S' .022" f. weld. max. 3 left
Published
2019-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EJFBRACKET, METAL, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
EJFBracket, Metal, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EFOR77523011PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
+4972314590info@forestadent.com

Regulatory Flags

DUNS number
316074384
Device count
1
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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EFOR4080610001Track bleach-408-06102023-08-11
EFOR129901001N.A.1299-01002020-03-01
EFOR129901011N.A.1299-01012020-03-01
EFOR129901021N.A.1299-01022020-03-01
EFOR32201101N.A.-322-01102020-03-01
EFOR32400010101N.A.-324-0001-0102020-02-01
EFOR32400011N.A.-324-00012020-02-01
EFOR32400020101N.A.-324-0002-0102020-02-01
EFOR32400021N.A.-324-00022020-02-01
EFOR32400031N.A.-324-00032020-02-01
EFOR32400041N.A.-324-00042020-02-01
EFOR32400051N.A.-324-00052020-02-01
EFOR32402001N.A.-324-02002020-02-01
EFOR32402101N.A.-324-02102020-02-01
EFOR16713231001N.A.-167-1323-1002019-12-01
EFOR16912391001N.A.-169-1239-1002019-12-01
EFOR16913231001N.A.-169-1323-1002019-12-01
EFOR16913251001N.A.-169-1325-1002019-12-01

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00190746191718Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191725Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191732Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191749Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191756Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191763Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
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00190746191787Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191794Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191800Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
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00190746191824Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191831Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191848Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191855Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191862Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191879Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191886Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191893Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23