SMILE WITH CONFIDENCE

Cushion, Denture, Over The Counter

LLOYD V. ZIEMENDORF

The following data is part of a premarket notification filed by Lloyd V. Ziemendorf with the FDA for Smile With Confidence.

Pre-market Notification Details

• Device ID: K971002
• 510k Number: K971002
• Device Name: SMILE WITH CONFIDENCE
• Classification: Cushion, Denture, Over The Counter
• Applicant: LLOYD V. ZIEMENDORF 6762 WARD RD. Niagara Falls, NY 14304 -4556
• Contact: Lloyd V Ziemendorf
• Correspondent: Lloyd V Ziemendorf; LLOYD V. ZIEMENDORF 6762 WARD RD. Niagara Falls, NY 14304 -4556
• Product Code: EHS
• CFR Regulation Number: 872.3540 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-03-19
• Decision Date: 1997-07-15