Splint, Endodontic Stabilizing

Device Code: 1248

Product Code(s): ELS

Device Classification Information

• Device Type ID: 1248
• Device Name: Splint, Endodontic Stabilizing
• Regulation Description: Endodontic Stabilizing Splint.
• 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: 872.3890 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: ELS
• 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)]
• 8-57 ISO 5832-2:1999
  Implants For Surgery -- Metallic Materials - Part 2: Unalloyed Titanium
• 8-406 ISO 5832-11 Second Edition 2014-09-15
  Implants For Surgery -- Metallic Materials -- Part 11: Wrought Titanium 6-aluminium 7-niobium Alloy
• 8-447 ISO 5832-3 Fourth Edition 2016-10-15
  Implants For Surgery -- Metallic Materials -- Part 3: Wrought Titanium 6-aluminium 4-vanadium Alloy
• 8-465 ISO 5832-2 Fourth Edition 2018-03
  Implants For Surgery - Metallic Materials - Part 2: Unalloyed Titanium

Total Product Life Cycle

• Device Type ID: 1248
• Device: Splint, Endodontic Stabilizing
• Product Code: ELS
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Endodontic Stabilizing Splint.
• CFR Regulation Number: 872.3890 [🔎]

TPLC Last Update: 2019-04-02 19:50:38