DiaPlus

Agent, Tooth Bonding, Resin

Diadent Group International

The following data is part of a premarket notification filed by Diadent Group International with the FDA for Diaplus.

Pre-market Notification Details

• Device ID: K192392
• 510k Number: K192392
• Device Name: DiaPlus
• Classification: Agent, Tooth Bonding, Resin
• Applicant: Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, KR 28161
• Contact: Kab Sun Lee
• Correspondent: Kab Sun Lee; Diadent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si, KR 28161
• Product Code: KLE
• CFR Regulation Number: 872.3200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-09-03
• Decision Date: 2020-05-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08806383565141	K192392	000