Needle, Dental

Device Code: 1107

Product Code(s): DZM

Device Classification Information

• Device Type ID: 1107
• Device Name: Needle, Dental
• Regulation Description: Dental Injecting Needle.
• 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: 872.4730 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: DZM
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 6-273 ISO 23908 First Edition 2011-06-11
  Sharps Injury Protection - Requirements And Test Methods - Sharps Protection Features For Single-use Hypodermic Needles, Introducers For Catheters And Needles Used For Blood Sampling

Total Product Life Cycle

• Device Type ID: 1107
• Device: Needle, Dental
• Product Code: DZM
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Dental Injecting Needle.
• CFR Regulation Number: 872.4730 [🔎]

Device Problems
Break	55
Detachment Of Device Or Device Component	7
Needle	6
Leak / Splash	3
Off-Label Use	2
Device Operates Differently Than Expected	2
Bent	1
Fracture	1
Adverse Event Without Identified Device Or Use Problem	1
Loss Of Or Failure To Bond	1
Detachment Of Device Component	1
Total Device Problems	80

TPLC Last Update: 2019-04-02 19:48:29