Smilers ALIGN_REPRO

GUDID 03770020010071

BIOTECH DENTAL SMILERS

Orthodontic progressive aligner
Primary Device ID03770020010071
NIH Device Record Key16166c12-b0f3-4b26-82fb-01fa9e8373d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmilers
Version Model NumberReproduction Aligner
Catalog NumberALIGN_REPRO
Company DUNS266048588
Company NameBIOTECH DENTAL SMILERS
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS103770020010071 [Unit of Use]
GS103770020010088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-28
Device Publish Date2022-04-20

On-Brand Devices [Smilers]

03770020010071Reproduction Aligner
03770020010057GOUTC for 2 archs
03770020010040Passive Appliance
03770020010026GOUTP for 2 archs
03770020010002aligners for 2 archs

Trademark Results [Smilers]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SMILERS
SMILERS
79236745 not registered Live/Pending
BIOTECH DENTAL SMILERS
2018-05-07
SMILERS
SMILERS
79234362 not registered Live/Pending
BIOTECH DENTAL SMILERS
2018-03-26
SMILERS
SMILERS
74127376 not registered Dead/Abandoned
SMILERS RED HOTS, INC.
1991-01-02

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