Candid Aligner

GUDID 00850004223222

Candid Aligner System FA-0003

CANDID CARE CO.

Orthodontic appliance system, progressive
Primary Device ID00850004223222
NIH Device Record Key60025fd7-ba58-437e-b578-fe4568ab21de
Commercial Distribution StatusIn Commercial Distribution
Brand NameCandid Aligner
Version Model NumberFA-0003
Company DUNS108729170
Company NameCANDID CARE CO.
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com
Phone917-754-2056
Emaildan.michaeli@candidco.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850004223222 [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 Date2020-09-07
Device Publish Date2020-08-28

On-Brand Devices [Candid Aligner]

00850004223222Candid Aligner System FA-0003
08500042230004Candid Aligner System FA-0001
00850004223567Candid Aligner System FA-0001

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