HY-BOND ZINC OXIDE EUGENOL TEMP.

Cement, Dental

SHOFU DENTAL CORP.

The following data is part of a premarket notification filed by Shofu Dental Corp. with the FDA for Hy-bond Zinc Oxide Eugenol Temp..

Pre-market Notification Details

• Device ID: K841196
• 510k Number: K841196
• Device Name: HY-BOND ZINC OXIDE EUGENOL TEMP.
• Classification: Cement, Dental
• Applicant: SHOFU DENTAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: EMA
• CFR Regulation Number: 872.3275 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-03-21
• Decision Date: 1984-05-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
E23511820	K841196	000
E23511810	K841196	000
E23511800	K841196	000