SUPPORT

Material, Tooth Shade, Resin

SCI-PHARM, INC.

The following data is part of a premarket notification filed by Sci-pharm, Inc. with the FDA for Support.

Pre-market Notification Details

• Device ID: K810479
• 510k Number: K810479
• Device Name: SUPPORT
• Classification: Material, Tooth Shade, Resin
• Applicant: SCI-PHARM, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-02-23
• Decision Date: 1981-03-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D801SP57031	K810479	000
D801SP510911	K810479	000
D801SP51302C1	K810479	000
D801SP51302CB1	K810479	000
D801SP57011	K810479	000
D801SP57011N1	K810479	000
D801SP57012N1	K810479	000
D801SP57013N1	K810479	000
D801SP57013T1	K810479	000
D801SP57013TN1	K810479	000
D801SP57021	K810479	000
D801SP51091	K810479	000