PAPAYA 3D & PAPAYA 3D Plus

FDA 510(k) K220392 · Genoray Co., Ltd.

Substantially Equivalent

510(k) numberK220392

Submission

Device name
PAPAYA 3D & PAPAYA 3D Plus
Applicant
Genoray Co., Ltd.
Seongnam-Si, KR
Received
February 11, 2022
Decision date
May 19, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAS – X-Ray, Tomography, Computed, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

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Questions and answers

When was PAPAYA 3D & PAPAYA 3D Plus cleared by the FDA?

PAPAYA 3D & PAPAYA 3D Plus (K220392) received a 510(k) decision of Substantially Equivalent on May 19, 2022, 97 days after the submission was received.

What is the product code of K220392?

The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.