Product Classification

• Device: sterilizer, endodontic dry heat
• Regulation Description: Endodontic dry heat sterilizer.
• Definition: Call for PMAs on 4/21/97 per 62 FR 2902 on 1/21/97
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: KOK
• Premarket Review: Division of Dental and ENT Devices (DHT1B); Division of Dental and ENT Devices (DHT1B)
• Submission Type: PMA
• Regulation Number: 872.6730
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Third Party Review

Not Third Party Eligible