Product Classification

• Device: lock, wire, and ligature, intraoral
• Regulation Description: Intraoral ligature and wire lock.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: DYX
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 872.4600
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 4-261 ISO 7405 Third edition 2018-10 Corrected version 2018-12
  Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• 8-405 ISO 5832-4 Third edition 2014-09-15
  Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
• 8-406 ISO 5832-11 Second edition 2014-09-15
  Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
• 8-435 ISO 5832-1 Fifth edition 2016-07-15
  Implants for surgery - Metallic materials - Part 1: Wrought stainless steel
• 8-465 ISO 5832-2 Fourth edition 2018-03
  Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
• 8-492 ISO 5832-9 Third edition 2019-02
  Implants for surgery - Metallic materials - Part 9: Wrought high nitrogen stainless steel
• 8-500 ISO 5832-12 Third edition 2019-02
  Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy
• 8-587 ISO 5832-3 Fifth Edition 2021-11
  Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
• 8-594 ISO 5832-6 Third Edition 2022-03
  Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy
• 8-595 ISO 5832-5 Fourth Edition 2022-03
  Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel
• 8-619 ISO 5832-4 Fourth edition 2024-04
  Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy
• 8-620 ISO 5832-11 Third edition 2024-03
  Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy
• 8-621 ISO 5832-1 Sixth edition 2024-04
  Implants for surgery - Metallic materials - Part 1: Wrought stainless steel

Third Party Review

Not Third Party Eligible