FDA.report

ELATION® MB

Primary DI
D807133212601
Brand
ELATION® MB
Company
DENTSPLY SIRONA ORTHODONTICS INC.
Model
133-212-60
Catalog number
133-212-60
Device description
ELATION® MB Base Rx 022/UL1 12T 5A
Published
2017-06-26
Public version status
Update
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
DYWBRACKET, PLASTIC, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D807133212601PrimaryHIBCC0
D807133212600Unit of UseHIBCC0

GMDN Terms

TermDefinition
Orthodontic bracket, plastic, single-useA plastic device intended to be bonded 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
+1(631)357-8600CustomerService_GAC@dentsplysirona.com

Regulatory Flags

DUNS number
116903307
Device count
5
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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