TipEdge PLUS Ceramic Readi-Base Bracket

GUDID 00192029005835

.022" LOWER BICUSPID - CCW 3.5 MM, PURPLE I.D. -20 TORQUE, 0 TIP

TP ORTHODONTICS INC

Orthodontic bracket, ceramic
Primary Device ID00192029005835
NIH Device Record Keyd81f7596-5023-4a9e-99c6-0e52cb0abc1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameTipEdge PLUS Ceramic Readi-Base Bracket
Version Model Number297-637
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100192029005835 [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 Date2019-02-12

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

00192029005859Upper Left Central +12 Torque, +5 Tip Oriented, 4 mm, Red 0.56 mm (.022")
00192029005842.022" LOWER BICUSPID - CW 3.5 MM, PURPLE I.D. -20 TORQUE, 0 TIP
00192029005835.022" LOWER BICUSPID - CCW 3.5 MM, PURPLE I.D. -20 TORQUE, 0 TIP
00192029005828.022" LOWER RIGHT ANTERIOR 3.5 MM, RED I.D. -1 TORQUE, 0 TIP
00192029005811.022" LOWER LEFT ANTERIOR 3.5 MM, RED I.D. -1 TORQUE, 0 TIP
00192029005804.022" UPPER BICUSPID - CW 3.5 MM, PURPLE I.D. -7 TORQUE, 0 TIP
00192029005798.022" UPPER BICUSPID - CCW 3.5 MM, PURPLE I.D. -7 TORQUE, 0 TIP
00192029005781.022" UPPER RIGHT LATERAL 3.5 MM, GREEN I.D. +8 TORQUE, +9 TIP
00192029005774.022" UPPER LEFT LATERAL 3.5 MM, GREEN I.D. +8 TORQUE, +9 TIP
00192029005767UPPER 5-5 CERAMIC, LOWER 5-5 METAL NON-EXTRACTION, WITH JIG .022" ARCHWIRE SLOT
00192029005750UPPER 5-5 CERAMIC, LOWER 5-5 METAL NON-EXTRACTION, WITHOUT JIG .022" ARCHWIRE SLOT
00192029005743UPPER 3-3 CERAMIC & 4-5 METAL LOWER 5-5 METAL, NON-EXTRACTION .022" ARCHWIRE SLOT, WITH
00192029005736UPPER 3-3 CERAMIC & 4-5 METAL LOWER 5-5 METAL, NON-EXTRACTION .022" ARCHWIRE SLOT, WITH
00192029005729LOWER 5 TO 5 NON-EXTRACTION .022" ARCHWIRE SLOT WITH JIGS
00192029005712LOWER 3 TO 3 .022" ARCHWIRE SLOT WITH JIGS
00192029005705UPPER & LOWER 5 TO 5 NON-EXTRACTION .022" ARCHWIRE SLOT WITH JIGS
00192029005699UPPER 5 TO 5 NON-EXTRACTION .022" ARCHWIRE SLOT WITH JIGS
00192029005675UPPER 3 TO 3 .022" ARCHWIRE SLOT WITH JIGS
00192029002681UPPER & LOWER 3 TO 3 .022" ARCHWIRE SLOT WITH JIGS

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