SHOFU PORCELAIN STAIN

Powder, Porcelain

SHOFU DENTAL CORP.

The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Shofu Porcelain Stain.

Pre-market Notification Details

• Device ID: K834497
• 510k Number: K834497
• Device Name: SHOFU PORCELAIN STAIN
• Classification: Powder, Porcelain
• Applicant: SHOFU DENTAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-12-20
• Decision Date: 1984-03-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
E23565610	K834497	000