Product Classification

• Device: splint, endodontic stabilizing
• Regulation Description: Endodontic stabilizing splint.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: ELS
• Submission Type: 510(k)
• Regulation Number: 872.3890
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• ISO 5832-11:1994 Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
• ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
• ISO 5832-2:1999 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.