Low Profile Cleats 852-166

GUDID 00190746133756

LINGUAL CLEAT CUSPID/BICUSPID

AMERICAN ORTHODONTICS CORPORATION

Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock Orthodontic lock
Primary Device ID00190746133756
NIH Device Record Key89864144-03ff-4410-a0e5-42be9d5f2c79
Commercial Distribution StatusIn Commercial Distribution
Brand NameLow Profile Cleats
Version Model Number852-166
Catalog Number852-166
Company DUNS044668515
Company NameAMERICAN ORTHODONTICS CORPORATION
Device Count1
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com
Phone+1(800)558-7687
Emailinfo@americanortho.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746133756 [Primary]

FDA Product Code

ECNCLAMP, WIRE, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-06
Device Publish Date2018-07-05

On-Brand Devices [Low Profile Cleats]

00190746133756LINGUAL CLEAT CUSPID/BICUSPID
00190746133206LINGUAL CLEAT MOLAR LOW PROFILE PK/100
00190746133190LINGUAL CLEAT MOLAR HEAVY DUTY PK/100
00190746133183LINGUAL CLEAT CUSPID/BICUSPID PK/100
00190746132964DB LINGUAL LOW PROFILE CLEAT 10/PKG
00190746125492LINGUAL CLEAT MOLAR HEAVY DUTY
00190746114748LINGUAL CLEAT MOLAR LOW PROFILE
00190746154973LINGUAL CLEAT MOLAR HEAVY DUTY

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