Cleared Traditional

UltraPrint-Dental Temp C&B UV

K213643 · Guangzhou Heygears IMC., Inc. · Dental

Jan 2022

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K213643 is an FDA 510(k) clearance for the UltraPrint-Dental Temp C&B UV, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Guangzhou Heygears IMC., Inc. (Guangzhou, CN). The FDA issued a Cleared decision on January 14, 2022, 57 days after receiving the submission on November 18, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number	K213643 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 18, 2021
Decision Date	January 14, 2022
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF