FDA.report

Forestanit®

Primary DI
EFOR21331101
Brand
Forestanit®
Company
Forestadent Bernhard Förster GmbH
Model
-213-3110
Device description
Forestanit wire round spring-hard clinic coil 1,10 mm
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
DZCWIRE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EFOR21331101PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic wireA thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is 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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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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