Wire, Orthodontic

Device Code: 1099

Product Code(s): DZC

Device Classification Information

• Device Type ID: 1099
• Device Name: Wire, Orthodontic
• Regulation Description: Orthodontic Appliance And Accessories.
• 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) Exempt
• CFR Regulation Number: 872.5410 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: DZC
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 8-150 ISO 5832-9 Second Edition 2007-06-15
  Implants For Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel
• 8-435 ISO 5832-1 Fifth Edition 2016-07-15
  Implants For Surgery - Metallic Materials - Part 1: Wrought Stainless Steel

Total Product Life Cycle

• Device Type ID: 1099
• Device: Wire, Orthodontic
• Product Code: DZC
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Orthodontic Appliance And Accessories.
• CFR Regulation Number: 872.5410 [🔎]

Device Problems
Material Fragmentation	2
Break	2
Insufficient Information	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Highland Metals, Inc.	II	Feb-03-2014
2	Ormco/Sybronendo	II	Nov-30-2015

TPLC Last Update: 2019-04-02 19:48:22