SOLAR

Unit, Operative Dental

ALPINE DENTAL EQUIPMENT CO.

The following data is part of a premarket notification filed by Alpine Dental Equipment Co. with the FDA for Solar.

Pre-market Notification Details

• Device ID: K854643
• 510k Number: K854643
• Device Name: SOLAR
• Classification: Unit, Operative Dental
• Applicant: ALPINE DENTAL EQUIPMENT CO. 325 ELMWOOD AVE. East Orange, NJ 07018
• Contact: Norman Smith
• Correspondent: Norman Smith; ALPINE DENTAL EQUIPMENT CO. 325 ELMWOOD AVE. East Orange, NJ 07018
• Product Code: EIA
• CFR Regulation Number: 872.6640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-11-19
• Decision Date: 1986-03-14