Qraypen— 510(k) K183121

Substantially Equivalent

AIOBIO Co., Ltd.

FDA 510(k) clearance K183121 for Qraypen, Substantially Equivalent on 2019-07-18. Applicant: AIOBIO Co., Ltd.. Device class: 1.

Clearance details

Applicant: AIOBIO Co., Ltd.
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 2018-11-09
Decision date: 2019-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIA

K251544 — Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)2026-08-07
K251626 — Midmark Dental Delivery System2025-11-03
K251491 — K5 Cart, K5 Mount, K5 Swing2025-07-17
K243130 — Integral Dental Unit2025-06-27
K242611 — Integral Dental Units2025-05-27

More clearances from AIOBIO Co., Ltd.

K221275 — Qraycam PRO2024-09-04

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