Pre-Finisher

GUDID 00192029041598

Non-Extraction

TP ORTHODONTICS INC

Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer
Primary Device ID00192029041598
NIH Device Record Keyba6cf518-c9d8-405c-982a-85a701e43cf7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePre-Finisher
Version Model Number190-057
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
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]
GS100192029041598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED
KMYPOSITIONER, TOOTH, PREFORMED

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-23
Device Publish Date2021-02-15

On-Brand Devices [Pre-Finisher]

00192029042632Asian Non-Extraction
00192029042625Asian Non-Extraction
00192029042618Asian Non-Extraction
00192029042601Asian Non-Extraction
00192029042595Asian Non-Extraction
00192029042588Asian Non-Extraction
00192029042571Asian Non-Extraction
00192029042564Asian Non-Extraction
00192029042557Asian 4 Bicuspid Extraction
00192029042540Asian 4 Bicuspid Extraction
00192029042533Asian 4 Bicuspid Extraction
00192029042526Asian 4 Bicuspid Extraction
00192029042519Asian 4 Bicuspid Extraction
00192029042502Asian 4 Bicuspid Extraction
00192029042496Asian 4 Bicuspid Extraction
00192029042489Asian 4 Bicuspid Extraction
00192029042472Asian 4 Bicuspid Extraction
00192029042465Asian 4 Bicuspid Extraction
00192029042458Asian 4 Bicuspid Extraction
00192029042441Asian 4 Bicuspid Extraction
00192029042434Asian 4 Bicuspid Extraction
00192029042427Asian 4 Bicuspid Extraction
001920290424104 Bicuspid Extraction w/Seating Springs
001920290424034 Bicuspid Extraction w/Seating Springs
001920290423974 Bicuspid Extraction w/Seating Springs
001920290423804 Bicuspid Extraction w/Seating Springs
001920290423734 Bicuspid Extraction w/Seating Springs
001920290423664 Bicuspid Extraction w/Seating Springs
001920290423594 Bicuspid Extraction w/Seating Springs
001920290423424 Bicuspid Extraction w/Seating Springs
001920290423354 Bicuspid Extraction w/Seating Springs
001920290423284 Bicuspid Extraction w/Seating Springs
001920290423114 Bicuspid Extraction w/Seating Springs
001920290423044 Bicuspid Extraction w/Seating Springs
001920290422984 Bicuspid Extraction w/Seating Springs
001920290422814 Bicuspid Extraction w/Seating Springs
001920290422744 Bicuspid Extraction w/Seating Springs
001920290422674 Bicuspid Extraction w/Seating Springs
001920290422504 Bicuspid Extraction w/Seating Springs
001920290422434 Bicuspid Extraction
001920290422364 Bicuspid Extraction
001920290422294 Bicuspid Extraction
001920290422124 Bicuspid Extraction
001920290422054 Bicuspid Extraction
001920290421994 Bicuspid Extraction
001920290421824 Bicuspid Extraction
001920290421754 Bicuspid Extraction
001920290421684 Bicuspid Extraction
001920290421514 Bicuspid Extraction
001920290421444 Bicuspid Extraction

Trademark Results [Pre-Finisher]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PRE-FINISHER
PRE-FINISHER
76535750 2878823 Live/Registered
TP Orthodontics, Inc.
2003-08-11
PRE-FINISHER
PRE-FINISHER
73161280 1119581 Dead/Expired
TP LABORATORIES, INC.
1978-03-07

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