FDA.report

n.A.

Primary DI
EFOR61300131
Brand
n.A.
Company
Forestadent Bernhard Förster GmbH
Model
-613-0013
Device description
Cervical traction band without clutch blue loose
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
DZBHeadgear, extraoral, orthodontic

Product Code Classifications

CodeDeviceSpecialtyClass
DZBHeadgear, Extraoral, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EFOR61300131PrimaryHIBCC0

GMDN Terms

TermDefinition
Orthodontic face bowA dental device used in conjunction with extraoral traction anchored on the back of the head or neck, as a long metal bow that inserts intraorally into an orthodontic appliance. Generally used to move teeth or bones posteriorly or prevent their forward movement.

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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