Intraoral Expansion Screws 855-2430

GUDID 00190746074424

MINI EXPANSION SCREW RAPID PALATAL 16MM (11MM EXPANSION)

AMERICAN ORTHODONTICS CORPORATION

Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable Orthodontic appliance system, adjustable
Primary Device ID00190746074424
NIH Device Record Key6739103d-007b-4565-8f50-da24ee4755c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntraoral Expansion Screws
Version Model Number855-2430
Catalog Number855-2430
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]
GS100190746074424 [Primary]

FDA Product Code

DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-14
Device Publish Date2020-09-04

On-Brand Devices [Intraoral Expansion Screws]

00190746075094FIXED FUNCT EXPANSION SCREW RAPID (13MM EXPANSION)
00190746075070FIXED FUNCT EXPANSION SCREW RAPID (9MM EXPANSION)
00190746074479FIXED FUNCT EXPANSION SCREW KEY 25/PKG
00190746074462FIXED FUNCT EXPANSION SCREW MEDIUM 14MM (9MM EXPANSION) 5/PKG
00190746074455FIXED FUNCT EXPANSION SCREW MICRO 10MM (6MM EXPANSION) 5/PKG
00190746074448FIXED FUNCT EXPANSION SCREW MEDIUM 11MM (7MM EXPANSION) 5/PKG
00190746074431FIXED FUNCT EXPANSION SCREW STANDARD 14MM (9MM EXPANSION) 5/PKG
00190746074417FIXED FUNCT EXPANSION SCREW RAPID PALATAL 15MM (11MM EXPANSION)
00190746074400FIXED FUNCT EXPANSION SCREW RAPID PALATAL 14MM (9MM EXPANSION)
00190746074387FIXED FUNCT EXPANSION SCREW RAPID PALATAL 12MM (8MM EXPANSION)
00190746074370FIXED FUNCT EXPANSION SCREW RAPID PALATAL 18MM (13MM EXPANSION)
00190746074486EXPANSION SCREW SMART SWIVEL KEY 10/PK
00190746074424MINI EXPANSION SCREW RAPID PALATAL 16MM (11MM EXPANSION)
00190746074394MINI EXPANSION SCREW RAPID PALATAL 13MM (8MM EXPANSION)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.