510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K173188Substantially Equivalent

The Graft Natural Bone Substitute

Purgo Biologics Inc., Seongnam-Si, KR / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K173188 is the FDA 510(k) clearance record for The Graft Natural Bone Substitute, a class II device, cleared for Purgo Biologics, Inc. on under FDA product code NPM (Bone Grafting Material, Animal Source). FDA's definition for product code NPM 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". FDA records list 6 510(k) clearances for Purgo Biologics, Inc., from to . As of , FDA records show no recalls naming K173188.

Clearance record

Decision date
Received
(291 days to decision)
Product code
NPM Bone Grafting Material, Animal Source
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Purgo Biologics, Inc. E-607, 700, Pangyo-Ro, Bundang-Gu, Seongnam-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPM

Trailing 12 months
2 clearances under product code NPM in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NPM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260