Inclusive® Zirconia Abutments Compatible With: Zimmer Screw-Vent, Biomet 3i Certain And Nobel Biocare NobelReplace Implants

Abutment, Implant, Dental, Endosseous

PRISMATIK DENTALCRAFT, INC.

The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Inclusive® Zirconia Abutments Compatible With: Zimmer Screw-vent, Biomet 3i Certain And Nobel Biocare Nobelreplace Implants.

Pre-market Notification Details

• Device ID: K143515
• 510k Number: K143515
• Device Name: Inclusive® Zirconia Abutments Compatible With: Zimmer Screw-Vent, Biomet 3i Certain And Nobel Biocare NobelReplace Implants
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: PRISMATIK DENTALCRAFT, INC. 2212 Dupont Dr., Suite P Irvine, CA 92612
• Contact: Brandon Shepard
• Correspondent: Brandon Shepard; PRISMATIK DENTALCRAFT, INC. 2212 Dupont Dr., Suite P Irvine, CA 92612
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-11
• Decision Date: 2015-10-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D745701054COM00460	K143515	000
D745701047COM00590	K143515	000
D745701047COM00600	K143515	000
D745701047COM00610	K143515	000
D745701051COM00590	K143515	000
D745701051COM00600	K143515	000
D745701051COM00610	K143515	000
D745701051COM00620	K143515	000
D745701054COM00440	K143515	000
D745701054COM00450	K143515	000
D745701047COM00580	K143515	000