510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222549Substantially Equivalent

OpenTex

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

K222549 is the FDA 510(k) clearance record for OpenTex, a class II device, cleared for Purgo Biologics, Inc. on under FDA product code NPK (Barrier, Synthetic, Intraoral). FDA's definition for product code NPK reads: "A synthetic dental barrier is a synthetic material device, such as ptfe, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials". FDA records list 6 510(k) clearances for Purgo Biologics, Inc., from to . As of , FDA records show no recalls naming K222549.

Clearance record

Decision date
Received
(261 days to decision)
Product code
NPK Barrier, Synthetic, Intraoral
Regulation
21 CFR 872.3930
Device class
Class II
Review panel
Dental
Applicant
Purgo Biologics, Inc. #812, 27 Dunchon-Daero 457 Beon-Gil, Jungwon-Gu, Seongnam-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NPK

Trailing 12 months

FDA records hold no clearances under product code NPK in the trailing twelve months.

FDA records show no clearances under product code NPK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NPK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260