FDA.report

Invisible Side-Winder Uprighting Spring

Primary DI
00192029027615
Brand
Invisible Side-Winder Uprighting Spring
Company
TP ORTHODONTICS INC
Model
214-010
Device description
CW
Published
2021-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ECOSPRING, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
ECOSpring, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192029027615PrimaryGS10

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

Regulatory Flags

DUNS number
005432299
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00192029050552Tip-Edge PLUS Stainless Steel Brackets296-61322025-02-04
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00192029050620Tip-Edge PLUS Stainless Steel Brackets296-62022025-02-04
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00192029050705Tip-Edge PLUS Stainless Steel Brackets296-63222025-02-04
00192029050712Tip-Edge PLUS Stainless Steel Brackets296-63322025-02-04
00192029050729Tip-Edge PLUS Stainless Steel Brackets296-63422025-02-04

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