INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE

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 Titanium Abutments Compatible With: Straumann Bone Level, Nobel Biocare Branae.

Pre-market Notification Details

• Device ID: K142118
• 510k Number: K142118
• Device Name: INCLUSIVE TITANIUM ABUTMENTS COMPATIBLE WITH: STRAUMANN BONE LEVEL, NOBEL BIOCARE BRANAE
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE SUITE P Irvine, CA 92627
• Contact: Brandon Shepard
• Correspondent: Brandon Shepard; PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE SUITE P Irvine, CA 92627
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-08-04
• Decision Date: 2014-11-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00842092163054	K142118	000
00842092115206	K142118	000
00842092115190	K142118	000
00842092114940	K142118	000
00842092114933	K142118	000
00842092114926	K142118	000
00842092114919	K142118	000
00842092114902	K142118	000
00842092162545	K142118	000
00842092162538	K142118	000
00842092139516	K142118	000
00842092101537	K142118	000
00842092101520	K142118	000
00842092180044	K142118	000
00842092162446	K142118	000
00842092115213	K142118	000
00842092115220	K142118	000
00842092163146	K142118	000
00842092114384	K142118	000
00842092139660	K142118	000
00842092138748	K142118	000
00842092135792	K142118	000
00842092135785	K142118	000
00842092129456	K142118	000
00842092129449	K142118	000
00842092129432	K142118	000
00842092129425	K142118	000
00842092129395	K142118	000
00842092129388	K142118	000
00842092129371	K142118	000
00842092129364	K142118	000
00842092162460	K142118	000