CAPS

Teeth, Porcelain

CHEMICHL, INC.

The following data is part of a premarket notification filed by Chemichl, Inc. with the FDA for Caps.

Pre-market Notification Details

• Device ID: K932012
• 510k Number: K932012
• Device Name: CAPS
• Classification: Teeth, Porcelain
• Applicant: CHEMICHL, INC. 17410 NE 195TH ST. Woodinville, WA 98072
• Contact: Daniel H Jonson
• Correspondent: Daniel H Jonson; CHEMICHL, INC. 17410 NE 195TH ST. Woodinville, WA 98072
• Product Code: ELL
• CFR Regulation Number: 872.3920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-04-23
• Decision Date: 1993-11-03