CERAMAX

Powder, Porcelain

ALPHADENT CO., LTD.

The following data is part of a premarket notification filed by Alphadent Co., Ltd. with the FDA for Ceramax.

Pre-market Notification Details

• Device ID: K062504
• 510k Number: K062504
• Device Name: CERAMAX
• Classification: Powder, Porcelain
• Applicant: ALPHADENT CO., LTD. 371-37, GASAN-DONG, GEUMCHEON-GU Seoul, KR 153-803
• Contact: Noh Hak
• Correspondent: Marc M Mouser; UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2006-08-28
• Decision Date: 2006-09-05
• Summary: summary