SHIELD

Liner, Cavity, Calcium Hydroxide

LORVIC CORP.

The following data is part of a premarket notification filed by Lorvic Corp. with the FDA for Shield.

Pre-market Notification Details

• Device ID: K780263
• 510k Number: K780263
• Device Name: SHIELD
• Classification: Liner, Cavity, Calcium Hydroxide
• Applicant: LORVIC CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: EJK
• CFR Regulation Number: 872.3250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-02-17
• Decision Date: 1978-05-03