Bracket, Ceramic, Orthodontic

Device Code: 1339

Product Code(s): NJM

Definition: An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position.

Device Classification Information

Device Type ID1339
Device NameBracket, Ceramic, Orthodontic
Regulation DescriptionOrthodontic Plastic Bracket.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(k)
CFR Regulation Number872.5470 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNJM
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID1339
DeviceBracket, Ceramic, Orthodontic
Product CodeNJM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionOrthodontic Plastic Bracket.
CFR Regulation Number872.5470 [🔎]
Premarket Reviews
ManufacturerDecision
3M COMPANY
 
SUBSTANTIALLY EQUIVALENT
1
3M HEALTH CARE
 
SUBSTANTIALLY EQUIVALENT
1
AJW TECHNOLOGY CONSULTANTS, INC.
 
SUBSTANTIALLY EQUIVALENT
1
CDB CORP.
 
SUBSTANTIALLY EQUIVALENT
1
ORMCO CORP.
 
SUBSTANTIALLY EQUIVALENT
2
ORTHO ORGANIZERS , INC.
 
SUBSTANTIALLY EQUIVALENT
1
PROGRESSIVE TECHNOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
1
SYBRON DENTAL SPECIALTIES, INC.
 
SUBSTANTIALLY EQUIVALENT
2
WORLD BIO TECH CO., LTD
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Adverse Event Without Identified Device Or Use Problem
5
Total Device Problems 5
TPLC Last Update: 2019-04-02 19:52:18

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