GENESIS

Material, Impression

PACIFIC RIM DENTAL, INC.

The following data is part of a premarket notification filed by Pacific Rim Dental, Inc. with the FDA for Genesis.

Pre-market Notification Details

• Device ID: K972871
• 510k Number: K972871
• Device Name: GENESIS
• Classification: Material, Impression
• Applicant: PACIFIC RIM DENTAL, INC. 173 SHADY LN. Stateline, NV 89449
• Contact: Kathy L Eppen
• Correspondent: Kathy L Eppen; PACIFIC RIM DENTAL, INC. 173 SHADY LN. Stateline, NV 89449
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-08-04
• Decision Date: 1997-10-02