TipEdge PLUS Ceramic Readi-Base Brackets

GUDID 00192029006832

.022" UPPER LEFT LATERAL

TP ORTHODONTICS INC

Orthodontic bracket, ceramic
Primary Device ID00192029006832
NIH Device Record Key45065145-2769-43fb-bf46-4deb7c3afd99
Commercial Distribution StatusIn Commercial Distribution
Brand NameTipEdge PLUS Ceramic Readi-Base Brackets
Version Model NumberRB297-629
Company DUNS005432299
Company NameTP ORTHODONTICS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029006832 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NJMBracket, ceramic, orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-11
Device Publish Date2019-02-08

On-Brand Devices [TipEdge PLUS Ceramic Readi-Base Brackets]

00192029006962.022" UPPER RIGHT CUSPID
00192029006955.022" UPPER LEFT CUSPID
00192029006948.022" LOWER BICUSPID-CW
00192029006931.022" LOWER BICUSPID-CCW
00192029006924.022" LOWER RIGHT CUSPID
00192029006917.022" LOWER LEFT CUSPID
00192029006900.022" UPPER BICUSPID-CW
00192029006894.022" UPPER BICUSPID-CCW
00192029006887.022" UPPER RIGHT CENTRAL
00192029006870.022" UPPER LEFT CENTRAL
00192029006863.022" LOWER RIGHT ANTERIOR
00192029006856.022" LOWER LEFT ANTERIOR
00192029006849.022" UPPER RIGHT LATERAL
00192029006832.022" UPPER LEFT LATERAL
00192029006825READI-BASE TIP-EDGE PLUS CERAMIC UPPER/LOWER 5-5 .022 KIT OR

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