Drill, Dental, Intraoral

Device Code: 1097

Product Code(s): DZA

Device Classification Information

• Device Type ID: 1097
• Device Name: Drill, Dental, Intraoral
• Regulation Description: Intraoral Dental Drill.
• 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: 872.4130 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: DZA
• 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: 1097
• Device: Drill, Dental, Intraoral
• Product Code: DZA
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Intraoral Dental Drill.
• CFR Regulation Number: 872.4130 [🔎]

Device Problems
Break	16
Fracture	5
Material Disintegration	1
Material Integrity Problem	1
Mechanical Problem	1
Component Falling	1
Detachment Of Device Component	1
Excessive Heating	1
Material Too Rigid Or Stiff	1
Material Separation	1
Total Device Problems	29

Recalls
Manufacturer		Recall Class	Date Posted
1	Zimmer Dental Inc	II	Sep-22-2017

TPLC Last Update: 2019-04-02 19:48:20