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NPMClass II

Bone Grafting Material, Animal Source

21 CFR 872.3930 / Dental

NPM is the FDA product code for Bone Grafting Material, Animal Source, a class II device type, regulated under 21 CFR 872.3930. FDA's definition for this code reads: "A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw". As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
NPM
Device name
Bone Grafting Material, Animal Source
FDA definition
A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.
Regulation
21 CFR 872.3930
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
41
Ingested recalls
11

Clearances, product code NPM

By decision year
41 clearances under product code NPM with a decision year between 2004 and 2026, 2017 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code NPM by decision year
YearClearances
20041
20051
20091
20102
20113
20122
20132
20142
20154
20161
20175
20182
20203
20212
20232
20243
20253
20262

Applicants with the most clearances

Product code NPM

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 43 companies shown, in name order