NRQ · Class II · 21 CFR 872.3640

FDA Product Code NRQ: Blade-form Endosseous Dental Implant

Device Made Of A Material Such As Titanium Or Titanium Alloy, That Is Intended To Be Surgically Placed In The Bone Of The Upper Or Lower Jaw Arches To Provide Support For Prosthetic Devices, Such As Artificial Teeth, In Order To Restore A Patient's Chewing Function.

Leading manufacturers include Rex Implants, Inc. and Depuy, Inc..

5
Total
5
Cleared
182d
Avg days
1979
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Blade-form Endosseous Dental Implant Devices (Product Code NRQ)

5 devices
1–5 of 5
Cleared Oct 12, 2022
PiezoImplant System
K211872
Rex Implants, Inc.
Dental · 482d
Cleared Sep 28, 1979
MITER ENDOSTEAL BLADE IMPLANT
K791204
Depuy, Inc.
Dental · 92d

About Product Code NRQ - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code NRQ since 1979, with 5 receiving FDA clearance (average review time: 182 days).

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