ALGINATE IMPRESSION MATERIAL

Material, Impression

DENTSPLY INTL.

The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Alginate Impression Material.

Pre-market Notification Details

• Device ID: K802362
• 510k Number: K802362
• Device Name: ALGINATE IMPRESSION MATERIAL
• Classification: Material, Impression
• Applicant: DENTSPLY INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1980-09-26
• Decision Date: 1980-10-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D6620708490672	K802362	000
D6620708490422	K802362	000