iSmile 40-1005

GUDID 20816419021925

Bite Tray Disposable Full Arch

Ismile Dental Products, Inc.

Dental impression tray, single-use
Primary Device ID20816419021925
NIH Device Record Key37e91885-b4dd-41cd-83dd-03ff65a1cecf
Commercial Distribution StatusIn Commercial Distribution
Brand NameiSmile
Version Model Number40-1005
Catalog Number40-1005
Company DUNS016765988
Company NameIsmile Dental Products, Inc.
Device Count40
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com
Phone916-928-0359
Emailinfo@ismiledp.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816419021921 [Primary]
GS120816419021925 [Unit of Use]

FDA Product Code

EBHMaterial, Impression Tray, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-29
Device Publish Date2023-06-21

On-Brand Devices [iSmile]

10816419023120VP Patient Bib 2-Ply Paper + 1-Ply Poly 13" x 18" Teal
20816419023110Saliva Ejector Clear with White Tip
20816419023080Earloop Mask Level 3 Black
10816419022543VP Patient Cups Plastic 5 oz Teal
10816419022536VP Patient Cups Plastic 5 oz Pink
10816419022529VP Patient Cups Plastic 5 oz White
10816419022512VP Patient Cups Plastic 5 oz Lavender
10816419022505VP Patient Cups Plastic 5 oz Green
10816419022499VP Patient Cups Plastic 5 oz Blue
10816419022482Sterilization Pouch 2-3/4" x 9" Bulk
10816419022178Isolation Gown Tie Back with Knit Cuff Yellow
10816419022161Isolation Gown Tie Back with Knit Cuff White
10816419022154Isolation Gown Tie Back with Knit Cuff Pink
10816419022147Isolation Gown Tie Back with Knit Cuff Green
10816419022130Isolation Gown Tie Back with Knit Cuff Blue
10816419022123Isolation Gown Tie Back with Elastic Cuff Yellow
10816419022116Isolation Gown Tie Back with Elastic Cuff White
10816419022109Isolation Gown Tie Back with Elastic Cuff Green
10816419022093Isolation Gown Tie Back with Elastic Cuff Pink
10816419022086Isolation Gown Tie Back with Elastic Cuff Blue
20816419022076X-Ray Head Sleeve 15" x 26"
20816419022069Light Handle Cover 4" x 5-3/4"
20816419022052Tray Sleeve Size F 7-1/2" x 10-1/2"
20816419022045Tray Sleeve Size C 11-5/8" x 16"
20816419022038Tray Sleeve Size B 10-1/2" x 14"
20816419022021Chair Sleeve Full 29" x 80"
20816419022014Chair Sleeve Half 27-1/2" x 24"
20816419022007Curing Light Sleeve 13-1/2" x 3-1/4" 3/4" Tip
20816419021994Curing Light Sleeve 13-1/2" x 2" 3/4" Tip
20816419021987Air/Water Syringe Sleeve 2-1/2" x 10" Clear
20816419021970Handpiece Sleeve 1-1/2" x 8" Clear
20816419021963Handpiece Sleeve 1" x 8" Clear
20816419021956Barrier Film 4" x 6" Clear
20816419021949Barrier Film 4" x 6" Blue
20816419021932Bite Tray Disposable Assortment
20816419021925Bite Tray Disposable Full Arch
20816419021918Bite Tray Disposable Sideless Posterior
20816419021901Bite Tray Disposable Quadrant
20816419021895Bite Tray Disposable Posterior
20816419021888Bite Tray Disposable Anterior
20816419021871Digital Sensor Cover 2-1/2" x 10"
20816419021864Digital Sensor Cover 1-3/8" x 8"
20816419021857Digital Sensor Cover 1-5/8" x 8"
20816419021840Surgical Aspirator Tip 1/16" Tip Blue
20816419021833Surgical Aspirator Tip 1/8" Tip White
20816419021826Surgical Aspirator Tip 1/4" Tip Green
20816419021819VP Impression Tray Perforated #7 Anterior Upper
20816419021802VP Impression Tray Perforated #9 Upper Right Lower Left
20816419021796VP Impression Tray Perforated #8 Upper Left Lower Right
20816419021789VP Impression Tray Perforated #4 Small Lower

Trademark Results [iSmile]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ISMILE
ISMILE
97235383 not registered Live/Pending
Blue Sky Bio LLC
2022-01-24
ISMILE
ISMILE
88851195 not registered Live/Pending
Liang Fanhua
2020-03-27
ISMILE
ISMILE
88015662 5661530 Live/Registered
Carl Zeiss Meditec AG
2018-06-26
ISMILE
ISMILE
87113230 not registered Dead/Abandoned
Shatkin, Todd E.
2016-07-22
ISMILE
ISMILE
86516393 not registered Dead/Abandoned
Hamada, Makarita R.
2015-01-28
ISMILE
ISMILE
78626966 not registered Dead/Abandoned
FROMM TOYS INC.
2005-05-10
ISMILE
ISMILE
77474318 not registered Dead/Abandoned
Reizenson, Igor
2008-05-14
ISMILE
ISMILE
77347551 not registered Dead/Abandoned
Reizenson, Igor
2007-12-09
ISMILE
ISMILE
76621394 not registered Dead/Abandoned
Reizenson, Igor
2004-11-19

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