LIMELIGHT

Liner, Cavity, Calcium Hydroxide

PULPDENT CORP.

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

Pre-market Notification Details

• Device ID: K953079
• 510k Number: K953079
• Device Name: LIMELIGHT
• Classification: Liner, Cavity, Calcium Hydroxide
• 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: EJK
• CFR Regulation Number: 872.3250 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-07-03
• Decision Date: 1995-08-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D701LIME32	K953079	000
D701LIME2	K953079	000