MIRROR SHIELD

Burnisher, Operative

PULPDENT CORP.

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

Pre-market Notification Details

• Device ID: K901053
• 510k Number: K901053
• Device Name: MIRROR SHIELD
• Classification: Burnisher, Operative
• Applicant: PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780
• Contact: Kenneth J Berk
• Correspondent: Kenneth J Berk; PULPDENT CORP. 80 OAKLAND ST. P.O. BOX 780 Watertown, MA 02471 -0780
• Product Code: EKJ
• CFR Regulation Number: 872.4565 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-03-05
• Decision Date: 1990-05-07