Cleared Traditional

Ambar, Ambar APS, Ambar Universal APS

K183424 · Dentscare Ltda · Dental

Dec 2019

Decision

367d

Days

Class 2

Risk

About This 510(k) Submission

K183424 is an FDA 510(k) clearance for the Ambar, Ambar APS, Ambar Universal APS, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Dentscare Ltda (Joinville, BR). The FDA issued a Cleared decision on December 13, 2019, 367 days after receiving the submission on December 11, 2018. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K183424 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2018
Decision Date	December 13, 2019
Days to Decision	367 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF