LZN · Class II · 21 CFR 878.3300

FDA Product Code LZN: Cement Obturator

37
Total
37
Cleared
121d
Avg days
1977
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Cement Obturator Devices (Product Code LZN)

37 devices
1–24 of 37
No devices found for this product code.

About Product Code LZN - Regulatory Context

510(k) Submission Activity

37 total 510(k) submissions under product code LZN since 1977, with 37 receiving FDA clearance (average review time: 121 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.