RENEW

Material, Tooth Shade, Resin

BISCO, INC.

The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Renew.

Pre-market Notification Details

• Device ID: K982729
• 510k Number: K982729
• Device Name: RENEW
• Classification: Material, Tooth Shade, Resin
• Applicant: BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193
• Contact: Kathy Joung
• Correspondent: Kathy Joung; BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-08-05
• Decision Date: 1998-09-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20810111541767	K982729	000
D757H812A3P1	K982729	000
D757H812B10	K982729	000
D757H812B1P1	K982729	000
D757H814A10	K982729	000
D757H814A1P1	K982729	000
D757H814A20	K982729	000
D757H814A2P1	K982729	000
D757H814A30	K982729	000
D757H812A35P1	K982729	000
D757H812A350	K982729	000
D757H812A30	K982729	000
10810111541708	K982729	000
10810111541715	K982729	000
10810111541722	K982729	000
10810111541746	K982729	000
D757H812A10	K982729	000
D757H812A1P1	K982729	000
D757H812A20	K982729	000
D757H812A2P1	K982729	000
D757H814A350	K982729	000
D757H814A35P1	K982729	000
D757H814A3P1	K982729	000
D757H814A1OP1	K982729	000
D757H814A35O0	K982729	000
D757H814A35OP1	K982729	000
D757H814C20	K982729	000
D757H814C2P1	K982729	000
D757H814D30	K982729	000
D757H814D3P1	K982729	000
D757C461A10	K982729	000
D757H814A1O0	K982729	000
D757H812D3P1	K982729	000
D757H812D30	K982729	000
D757H814B10	K982729	000
D757H814B1P1	K982729	000
D757H812A1O0	K982729	000
D757H812A1OP1	K982729	000
D757H812A35O0	K982729	000
D757H812A35OP1	K982729	000
D757H812C20	K982729	000
D757H812C2P1	K982729	000
D757C462BL0	K982729	000