Bracket, Plastic, Orthodontic

Device Code: 1095

Product Code(s): DYW

Device Classification Information

• Device Type ID: 1095
• Device Name: Bracket, Plastic, Orthodontic
• Regulation Description: Orthodontic Plastic Bracket.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Dental Devices Branch (DEDB)
• Submission Type: 510(k)
• CFR Regulation Number: 872.5470 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: DYW
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 4-212 ISO 7405 Second Edition 2008-12-15
  Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
• 4-218 ISO 27020 First Edition 2010-12-15
  Dentistry - Brackets And Tubes For Use In Orthodontics

Total Product Life Cycle

• Device Type ID: 1095
• Device: Bracket, Plastic, Orthodontic
• Product Code: DYW
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Orthodontic Plastic Bracket.
• CFR Regulation Number: 872.5470 [🔎]

Premarket Reviews
Manufacturer	Decision
BLUE SKY BIO
	SUBSTANTIALLY EQUIVALENT	1
GREAT LAKES ORTHODONTICS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO ORGANIZERS , INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHO SPECIALTIES
	SUBSTANTIALLY EQUIVALENT	1
TOMY, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Loose Or Intermittent Connection	1
Failure To Osseointegrate	1
Total Device Problems	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Ormco/Sybronendo	II	Apr-04-2014

TPLC Last Update: 2019-04-02 19:48:19