FDA.report

SENTALLOY®

Primary DI
D80702000000
Brand
SENTALLOY®
Company
DENTSPLY SIRONA ORTHODONTICS INC.
Model
02-000-00
Catalog number
02-000-00
Device description
SENTALLOY® UP SPRING PKG 10 RIGHT
Published
2020-09-24
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
ECOSPRING, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECOSpring, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D80702000001PrimaryHIBCC0
D80702000000Unit of UseHIBCC0

GMDN Terms

TermDefinition
Orthodontic springA dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. 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
+1(833)372-8255CustomerService_GAC@dentsplysirona.com

Regulatory Flags

DUNS number
116903307
Device count
10
DM exempt
true
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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