BOSS— 510(k) K253723

Name: FDA 510(k) clearance K253723
Creator: U.S. Food and Drug Administration
Published: 2026-06-16

Substantially Equivalent

Medpark Co., Ltd.

FDA 510(k) clearance K253723 for BOSS, Substantially Equivalent on 2026-06-16. Applicant: Medpark Co., Ltd.. Device class: 2.

Summary

BOSS from Medpark is filed under NPM, animal-source bone grafting materials. The record doesn't expand the name or describe the material beyond the code name.

Class II, 21 CFR 872.3930. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Medpark filed from Busan, South Korea. Review took 204 calendar days (November 24, 2025 to June 16, 2026).

Clearance details

Applicant: Medpark Co., Ltd.
Product code: Product code NPM
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2025-11-24
Decision date: 2026-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Busan, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code NPM

view all

K260096 — Wishbone HAE2026-10-09
K254210 — REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5)2026-09-25
K251786 — Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®2025-07-11
K251613 — SwissGraft X2025-06-26
K242510 — Geistlich Bio-Flow®2025-03-07

More clearances from Medpark Co., Ltd.

view all

K231672 — S12023-10-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.