Handle, Instrument, Dental

Device Code: 1195

Product Code(s): EJB

Device Classification Information

• Device Type ID: 1195
• Device Name: Handle, Instrument, Dental
• Regulation Description: Dental Hand Instrument.
• 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: 872.4565 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: EJB
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 8-150 ISO 5832-9 Second Edition 2007-06-15
  Implants For Surgery - Metallic Materials - Part 9: Wrought High Nitrogen Stainless Steel
• 8-435 ISO 5832-1 Fifth Edition 2016-07-15
  Implants For Surgery - Metallic Materials - Part 1: Wrought Stainless Steel

Total Product Life Cycle

• Device Type ID: 1195
• Device: Handle, Instrument, Dental
• Product Code: EJB
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Dental Hand Instrument.
• CFR Regulation Number: 872.4565 [🔎]

Premarket Reviews
Manufacturer	Decision
CENTRIX, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Detachment Of Device Component	2
Fracture	2
Break	1
Total Device Problems	5

TPLC Last Update: 2019-04-02 19:49:48