KERATOR

Abutment, Implant, Dental, Endosseous

KJ MEDITECH CO., LTD

The following data is part of a premarket notification filed by Kj Meditech Co., Ltd with the FDA for Kerator.

Pre-market Notification Details

• Device ID: K112787
• 510k Number: K112787
• Device Name: KERATOR
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: KJ MEDITECH CO., LTD 951 STARBUCK ST. UNIT J Fullerton, CA 92833
• Contact: Pricilla Chung
• Correspondent: Pricilla Chung; KJ MEDITECH CO., LTD 951 STARBUCK ST. UNIT J Fullerton, CA 92833
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-26
• Decision Date: 2012-08-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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