SPECTRUM

Teeth, Porcelain

DENTSPLY INTL.

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

Pre-market Notification Details

• Device ID: K880774
• 510k Number: K880774
• Device Name: SPECTRUM
• Classification: Teeth, Porcelain
• Applicant: DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405
• Contact: John O Semmelman
• Correspondent: John O Semmelman; DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405
• Product Code: ELL
• CFR Regulation Number: 872.3920 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1988-02-26
• Decision Date: 1988-05-18