FDA.report

N.A.

Primary DI
EFOR30710651
Brand
N.A.
Company
Forestadent Bernhard Förster GmbH
Model
-307-1065
Device description
Power-Arm .022"
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

Contact Domains

Product Codes

CodeName
ECNCLAMP, WIRE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECNClamp, Wire, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EFOR30710651PrimaryHIBCC0
EFOR307106511Unit of UseHIBCC0

GMDN Terms

TermDefinition
Orthodontic power arm/lockAn orthodontic device in the shape of a straight pin or hook designed to accept an elastic band, power chain, spring, or archwire (not included), which apply a force in addition to the main orthodontic archwire, for vertical alignment and/or horizontal positioning of the teeth; it also includes a base that functions as an orthodontic lock/stop. The device is crimped, soldered or screwed on an orthodontic attachment (e.g., bracket, archwire) or the surface of a tooth. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.

Sterilization Methods

Method

Contacts

PhoneEmail
+4972314590info@forestadent.com

Regulatory Flags

DUNS number
316074384
Device count
10
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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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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