BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, Bleach White

Registration Details

Registration Name: PRISMATIK DENTALCRAFT, INC.
Registration Number: 3011649314
FEI Number: 3011649314
Status: Active
Expiry Year: 2025
Initial Importer: Yes
Address: 2144 Michelson Drive
City: Irvine
State: CA
ZIP: 92612
Country: US

Regulatory Submissions

510(k) Number: K231940

Owner / Operator

Firm Name: PRISMATIK DENTALCRAFT, INC.
Operator Number: 10043585
Address: 2144 Michelson Drive
City: Irvine
State: CA
Postal Code: 92612
Country: US
Correspondent: Michelle Gallup

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Dental Abutment Design Software For Dental Laboratory	PNP	Class 2	Dental	No	2024-11-06
Abutment, Implant, Dental, Endosseous	NHA	Class 2	Dental	No	2024-11-06

Proprietary Names

BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, Bleach White BruxZir® NOW SRC for Hahn Implant System 7 mm, A3.5 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, C3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, B1 BruxZir® NOW SRC for Hahn Implant System 5 mm, D2 BruxZir® NOW SRC for Hahn Implant System 5 mm, B1 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, A4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, A3 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, B2 BruxZir® NOW SRC for Hahn Implant System 7 mm, D2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, A4 BruxZir® NOW SRC for Hahn Implant System 5 mm, A3 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, B4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, A3 BruxZir® NOW SRC for Hahn Implant System 7 mm, C4 BruxZir® NOW SRC for Hahn Implant System 5 mm, Bleach1 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, C3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, C2 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, C2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, B1 BruxZir® NOW SRC for Hahn Implant System 5 mm, A3.5 BruxZir® NOW SRC for Hahn Implant System 7 mm, Bleach3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, D2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, Bleach3 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, A3 BruxZir® NOW SRC for Hahn Implant System 7 mm, C1 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, Bleach3 BruxZir® NOW SRC for Hahn Implant System 7 mm, Bleach1 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, B1 BruxZir® NOW SRC for Hahn Implant System 5 mm, A2 BruxZir® NOW SRC for Hahn Implant System 7 mm, A3 BruxZir® NOW SRC for Hahn Implant System 7 mm, D3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, D4 BruxZir® NOW SRC for Hahn Implant System 7 mm, A2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, C2 BruxZir® NOW SRC for Hahn Implant System 7 mm, C2 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, C1 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, C4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, C1 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, A3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, A3.5 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, A3.5 BruxZir® NOW SRC for Hahn Implant System 5 mm, B3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, C1 BruxZir® NOW SRC for Hahn Implant System 5 mm, C1 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, C3 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, D4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, A2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, A4 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, Bleach1 BruxZir® NOW SRC for Hahn Implant System 5 mm, D4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, A2 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, D2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, C4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, B2 BruxZir® NOW SRC for Hahn Implant System 7 mm, C3 BruxZir® NOW SRC for Hahn Implant System 5 mm, B2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, A1 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, B1 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, B4 BruxZir® NOW SRC for Hahn Implant System 7 mm, B4 BruxZir® NOW SRC for Hahn Implant System 7 mm, B1 BruxZir® NOW SRC for Hahn Implant System 5 mm, A1 BruxZir® NOW SRC for Hahn Implant System 7 mm, B2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, Bleach1 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, D4 BruxZir® NOW SRC for Hahn Implant System 5 mm, B4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, D2 BruxZir® NOW SRC for Hahn Implant System 7 mm, A1 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, Bleach3 BruxZir® NOW SRC for Hahn Implant System 5 mm, Bleach White BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, B3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, D3 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, B3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, A1 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, B3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, A2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, Bleach1 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, A2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, D3 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, A3.5 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, A1 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, Bleach White BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, B2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, A1 BruxZir® NOW SRC for Hahn Implant System 7 mm, Bleach White BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, B3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, B4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, D4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, Bleach1 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, Bleach White BruxZir® NOW SRC for Hahn Implant System 5 mm, C3 BruxZir® NOW SRC for Hahn Implant System 7 mm, D4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, C4 BruxZir® NOW SRC for Hahn Implant System 5 mm, C4 BruxZir® NOW SRC for Hahn Implant System 5 mm, Bleach3 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, Bleach3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, A3.5 BruxZir® NOW SRC for Hahn Implant System 5 mm, C2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, D3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, D2 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, B4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, C3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, C4 BruxZir® NOW SRC for Hahn Implant System 3.5/4.3mm, D3 BruxZir® NOW SRC for Hahn Implant System 5 mm, D3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, Bleach White BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.2 mm, A4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 4.7/5.2 mm, B2 BruxZir® NOW SRC for Hahn Implant System 7 mm, B3 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, C2 BruxZir® NOW SRC for Hahn Implant System 7 mm, A4 BruxZir® NOW SRC for Inclusive® Tapered Implant System 3.7/4.2 mm, C1 BruxZir® NOW SRC for Hahn Implant System 5 mm, A4

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device