FDA.report

Mini Sprint ®

Primary DI
EFOR79415111001
Brand
Mini Sprint ®
Company
Forestadent Bernhard Förster GmbH
Model
-794-1511-100
Device description
Mini Sprint II Bracket FACE Evolution II System .022" mand. 4 right
Published
2019-10-02
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
EFOR79415111001PrimaryHIBCC0
EFOR79415111000011Unit of UseHIBCC0

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
100
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

Other Devices From This Company

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EFOR5011845Special instrument for opening of BioQui-501-18452024-11-29
EFOR5011846Two pronged probe for BioQuick Brackets-501-18462024-11-30
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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00190746191619Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
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00190746191633Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191640Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191657Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191664Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191671Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191688Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191695Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191701Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
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
00190746191770Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191787Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191794Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191800Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
00190746191817Empower BracketAMERICAN ORTHODONTICS CORPORATIONEJF2026-03-23
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