Alloy, Gold-based Noble Metal

Device Code: 1208

Product Code(s): EJT

Device Classification Information

• Device Type ID: 1208
• Device Name: Alloy, Gold-based Noble Metal
• Regulation Description: Noble Metal Alloy.
• 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: 872.3060 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: EJT
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 4-86 ADA ANSI Specification No. 38 2000 (R2015)
  Metal-Ceramic Dental Restorative Systems
• 4-92 ADA ANSI Specification No. 88 (Reaffirmed 2012)
  Dental Brazing Alloys
• 4-201 ISO 9693-1 First Edition 2012-02-15
  Dentistry -- Compatibility Testing - Part 1: Metal-ceramic Systems
• 4-212 ISO 7405 Second Edition 2008-12-15
  Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
• 4-227 ISO 22674 Second Edition 2016-01-15
  Dentistry - Metallic Materials For Fixed And Removable Restorations And Appliances
• 4-243 ADA ANSI Standard No. 97:2002/ISO 10271:2001 Reaffirmed By ANSI: May 29, 2013
  Corrosion Test Methods
• 4-245 ISO 10271 Second Edition 2011-08-01
  Dentistry - Corrosion Test Methods For Metallic Materials
• 4-247 ISO 28319 Second Edition 2018-04
  Dentistry - Laser Welding And Filler Materials

Total Product Life Cycle

• Device Type ID: 1208
• Device: Alloy, Gold-based Noble Metal
• Product Code: EJT
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Noble Metal Alloy.
• CFR Regulation Number: 872.3060 [🔎]

Device Problems
Device Operational Issue	1
Total Device Problems	1

TPLC Last Update: 2019-04-02 19:50:01