510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NRQClass II

Blade-Form Endosseous Dental Implant

21 CFR 872.3640 / Dental
FDA source (opens on fda.gov)

NRQ is the FDA product code for Blade-Form Endosseous Dental Implant, a class II device type, regulated under 21 CFR 872.3640. FDA's definition for this code reads: "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". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NRQ
Device name
Blade-Form Endosseous Dental Implant
FDA definition
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.
Regulation
21 CFR 872.3640
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code NRQ

By decision year
5 clearances under product code NRQ with a decision year between 1979 and 2022, 1979 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NRQ by decision year
YearClearances
19792
19821
19991
20221

Applicants with the most clearances

Product code NRQ
Applicants holding the most 510(k) clearances under product code NRQ
ApplicantClearances
Depuy, Inc.1
Healthline Implants, Inc.1
Leonard P. Linkow, D.D.L.1
Oratronics, Inc.1
Rex Implants, Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code