Glidewell HT Implant Titanium Abutment Blank - 6 mm

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: K143353

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
Implant, Endosseous, Root-Form	DZE	Class 2	Dental	No	2015-06-12

Proprietary Names

Glidewell HT Implant Titanium Abutment Blank - 6 mm Glidewell HT Implant Non-Engaging Temporary Abutment - 6 Implant Glidewell HT Implant Multi-Unit Abutment 4.5 mmH - 6 Implant Glidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH - 6 Implant Glidewell HT Implant Multi-Unit Abutment 2.5 mmH - 6 Implant Glidewell HT Implant Healing Abutment 3 mmH - 6 Implant Glidewell HT Implant Titanium Abutment 4.5 mmH - 6 Implant Glidewell HT Implant GL Titanium Abutment 6 mmH - 6 Implant Glidewell HT Implant Multi-Unit Abutment 1.5 mmH - 6 Implant Glidewell HT Implant Posterior Esthetic Abutment 6 Implant Hahn Tapered Implant 30 Multi-Unit Abutment 3.5 mmH - 3.5/4.3 Implant Hahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 5 Implant Hahn Tapered Implant UCLA Gold - 5 Implant Hahn Tapered Implant Non-Engaging Titanium Abutment 4.5 mmH - 7 Implant Glidewell HT Implant 30° Multi-Unit Abutment 3.5 mmH - 3.5/4.3 Implant Glidewell HT Implant Titanium Abutment 4.5 mmH - 3.5/4.3 Implant Glidewell HT Implant Titanium Abutment 6 mmH - 7 Implant Glidewell HT Implant Multi-Unit Abutment 3.5 mmH - 3.5/4.3 Implant Hahn Tapered Implant Non-Engaging UCLA Gold - 7 Implant Hahn Tapered Implant Non-Engaging Temporary Abutment - 3 Implant Hahn Tapered Implant Titanium Abutment Blank - 5 Implant Glidewell HT Implant 4.3 x 10 mm Glidewell HT Implant 3.5 x 10 mm Hahn Tapered Implant 3.5 x 13 mm Hahn Tapered Implant Healing Abutment 3 mmH - 3.5 Implant Glidewell HT Implant Non-Engaging UCLA Gold - 3.5/4.3 Implant Glidewell HT Implant 17° Multi-Unit Abutment 3.5 mmH - 5 Implant Glidewell HT Implant GL Titanium Abutment 4.5 mmH - 3 Implant Hahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 3 Implant Hahn Tapered Implant Non-Engaging UCLA Gold - 5 Implant Hahn Tapered Implant Titanium Abutment 4.5 mmH - 3 Implant Hahn Tapered Implant 5 x 13 mm Hahn Tapered Implant Titanium Screw - 5/7 Implant Hahn Tapered Implant 4.3 x 11.5 mm Glidewell HT Implant Multi-Unit Abutment 1.5 mmH - 5 Implant Glidewell HT Implant Healing Abutment 3 mmH - 5 Implant Hahn Tapered Implant Non-Engaging Temporary Abutment - 7 Implant Hahn Tapered Implant Titanium Abutment 6 mmH - 7 Implant Glidewell HT Implant Titanium Abutment 4.5 mmH - 3 Implant Glidewell HT Implant GL Titanium Abutment 6 mmH - 3.5/4.3 Implant Glidewell HT Implant Multi-Unit Abutment 2.5 mmH - 3 Implant Glidewell HT Implant 7 x 8 mm Hahn Tapered Implant Non-Engaging Titanium Abutment 4.5 mmH - 5 Implant Hahn Tapered Implant Non-Engaging Titanium Abutment 4.5 mmH - 3 Implant Hahn Tapered Implant Healing Abutment 5 mmH - 4.3 Implant Hahn Tapered Implant Non-Engaging UCLA Gold - 3.5/4.3 Implant Hahn Tapered Implant Healing Abutment 3 mmH - 5 Implant Hahn Tapered Implant Titanium Screw - 3.5/4.3 Implant (5-pack) Hahn Tapered Implant 17 Multi-Unit Abutment 3.5 mmH - 3.5/4.3 Implant Glidewell HT Implant Healing Abutment 7 mmH - 3 Implant Glidewell HT Implant 17° Multi-Unit Abutment 2.5 mmH - 5 Implant Glidewell HT Implant Healing Abutment 5 mmH - 3 Implant Hahn Tapered Implant 7 x 11.5 mm Hahn Tapered Implant GL Titanium Abutment 6 mmH - 5 Implant Hahn Tapered Implant Temporary Abutment - 5 Implant Hahn Tapered Implant Titanium Abutment 4.5 mmH - 3 Implant Glidewell HT Implant UCLA Gold - 5 Implant Glidewell HT Implant UCLA Gold - 3 Implant Glidewell HT Implant Multi-Unit Abutment 3.5 mmH - 5 Implant Hahn Tapered Implant Titanium Abutment 4.5 mmH - 5 Implant Hahn Tapered Implant 4.3 x 16 mm Hahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 3.5/4.3 Implant Glidewell HT Implant 3.5 x 8 mm Glidewell HT Implant Titanium Abutment Blank - 3.5/4.3 Implant Hahn Tapered Implant Titanium Abutment Blank - 3.5/4.3 Implant Hahn Tapered Implant UCLA Gold - 7 Implant Hahn Tapered Implant Guide Pin - 5/7 Implant (5-pack) Glidewell HT Implant UCLA Gold - 7 Implant Glidewell HT Implant Healing Abutment 5 mmH - 3.5 Implant Glidewell HT Implant Healing Abutment 3 mmH - 3 Implant Glidewell HT Implant Healing Abutment 5 mmH - 5 Implant Hahn Tapered Implant 15 Posterior Esthetic Abutment - 5 Implant Hahn Tapered Implant 30 Multi-Unit Abutment 3.5 mmH - 5 Implant Hahn Tapered Implant Non-Engaging Temporary Abutment - 3 Implant Hahn Tapered Implant Titanium Abutment 6 mmH - 5 Implant Glidewell HT Implant 17° Multi-Unit Abutment 2.5 mmH - 3.5/4.3 Implant Glidewell HT Implant Non-Engaging UCLA Gold - 3 Implant Glidewell HT Implant Non-Engaging Temporary Abutment - 5 Implant Glidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH - 7 Implant Hahn Tapered Implant Healing Abutment 3 mmH - 3 Implant Hahn Tapered Implant Healing Abutment 3 mmH - 7 Implant Hahn Tapered Implant Posterior Esthetic Abutment - 7 Implant Hahn Tapered Implant 30 Multi-Unit Abutment 4.5 mmH - 5 Implant Glidewell HT Implant 30° Multi-Unit Abutment 4.5 mmH - 5 Implant Hahn Tapered Implant Posterior Esthetic Abutment - 5 Implant Hahn Tapered Implant Non-Engaging Titanium Abutment 4.5 mmH - 5 Implant Hahn Tapered Implant Titanium Abutment 4.5 mmH - 3.5/4.3 Implant Glidewell HT Implant Titanium Abutment 6 mmH - 5 Implant Glidewell HT Implant Healing Abutment 7 mmH - 3.5 Implant Glidewell HT Implant 4.3 x 8 mm Glidewell HT Implant 7 x 10 mm Glidewell HT Implant Multi-Unit Abutment 3.5 mmH - 3 Implant Hahn Tapered Implant Titanium Screw - 3 Implant Hahn Tapered Implant Healing Abutment 5 mmH - 3 Implant Hahn Tapered Implant Non-Engaging Temporary Abutment - 3.5/4.3 Implant Hahn Tapered Implant Non-Engaging Titanium Abutment 4.5 mmH - 7 Implant Hahn Tapered Implant GL Titanium Abutment 4.5 mmH - 5 Implant Glidewell HT Implant 4.3 x 13 mm Glidewell HT Implant 3.5 x 16 mm Hahn Tapered Implant Temporary Abutment - 3.5/4.3 Implant Hahn Tapered Implant Healing Abutment 7 mmH - 3 Implant Glidewell HT Implant Temporary Abutment - 3.5/4.3 Implant Glidewell HT Implant 15° Anterior Esthetic Abutment - 5 Implant Hahn Tapered Implant Non-Engaging Temporary Abutment - 3.5/4.3 Implant Hahn Tapered Implant Angled Multi-Unit Abutment Screw - 3.5/4.3 Implant Hahn Tapered Implant Multi-Unit Abutment 1.5 mmH - 5 Implant Glidewell HT Implant Titanium Abutment Blank 7 Implant Glidewell HT Implant Non-Engaging Temporary Abutment - 3 Implant Hahn Tapered Implant Healing Abutment 3 mmH - 4.3 Implant Hahn Tapered Implant 5 x 16 mm Hahn Tapered Implant Titanium Abutment 6 mmH - 3 Implant Glidewell HT Implant 4.3 x 11.5 mm Glidewell HT Implant Non-Engaging UCLA Gold - 5 Implant Hahn Tapered Implant 30 Multi-Unit Abutment 4.5 mmH - 3.5/4.3 Implant Hahn Tapered Implant Titanium Abutment 4.5 mmH - 5 Implant Glidewell HT Implant Temporary Abutment - 3 Implant Glidewell HT Implant Healing Abutment 3 mmH - 3.5 Implant Glidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH - 3 Implant Glidewell HT Implant 6 x 11.5 mm Hahn Tapered Implant 5 x 8 mm Hahn Tapered Implant UCLA Gold - 3.5/4.3 Implant Hahn Tapered Implant Titanium Abutment 4.5 mmH - 7 Implant Glidewell HT Implant 4.3 x 16 mm Glidewell HT Implant Titanium Abutment Blank 5 Implant Hahn Tapered Implant Titanium Abutment Blank - 3 Implant Hahn Tapered Implant 15 Anterior Esthetic Abutment - 5 Implant Glidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH - 3.5/4.3 Implant Glidewell HT Implant 3 x 16 mm Glidewell HT Implant Non-Engaging Titanium Abutment 4.5 mmH - 5 Implant Glidewell HT Implant Multi-Unit Abutment 3.5 mmH - 6 Implant Hahn Tapered Implant Temporary Abutment - 3 Implant Hahn Tapered Implant Guide Pin - 3.5/4.3 Implant Hahn Tapered Implant GL Titanium Abutment 4.5 mmH - 7 Implant Hahn Tapered Implant 3 x 11.5 mm Hahn Tapered Implant Temporary Abutment - 7 Implant Hahn Tapered Implant Temporary Abutment - 5 Implant Hahn Tapered Implant 15 Anterior Esthetic Abutment - 3.5/4.3 Implant Hahn Tapered Implant Temporary Abutment - 7 Implant Glidewell HT Implant 5 x 8 mm Hahn Tapered Implant Temporary Abutment - 3 Implant Hahn Tapered Implant Guide Pin - 5/7 Implant Glidewell HT Implant Healing Abutment 3 mmH - 4.3 Implant Glidewell HT Implant Healing Abutment 3 mmH - 7 Implant Glidewell HT Implant 15° Posterior Esthetic Abutment - 5 Implant Hahn Tapered Implant Anterior Esthetic Abutment - 5 Implant Hahn Tapered Implant Titanium Abutment 6 mmH - 3.5/4.3 Implant Hahn Tapered Implant Anterior Esthetic Abutment - 3.5/4.3 Implant Hahn Tapered Implant 3 x 16 mm Glidewell HT Implant GL Titanium Abutment 6 mmH - 7 Implant Hahn Tapered Implant Guide Pin - 3.5/4.3 Implant (5-pack) Hahn Tapered Implant Titanium Screw - 5/7 Implant (5-pack) Glidewell HT Implant 30° Multi-Unit Abutment 3.5 mmH - 5 Implant Glidewell HT Implant 30° Multi-Unit Abutment 4.5 mmH - 3.5/4.3 Implant Hahn Tapered Implant 3.5 x 10 mm Glidewell HT Implant Titanium Abutment 4.5 mmH - 7 Implant Glidewell HT Implant Posterior Esthetic Abutment - 5 Implant Glidewell HT Implant Healing Abutment 7 mmH - 5 Implant Glidewell HT Implant GL Titanium Abutment 6 mmH - 5 Implant Glidewell HT Implant 15° Anterior Esthetic Abutment - 3.5/4.3 Implant Glidewell HT Implant 6 x 10 mm Glidewell HT Implant Temporary Abutment - 6 Implant Glidewell HT Implant Healing Abutment 5 mmH - 6 Implant Glidewell HT Implant Titanium Screw 5/6 Implant Glidewell HT Implant 6 x 8 mm Hahn Tapered Implant 17 Multi-Unit Abutment 3.5 mmH - 5 Implant Hahn Tapered Implant 3.5 x 16 mm Hahn Tapered Implant 7 x 8 mm Hahn Tapered Implant 4.3 x 13 mm Hahn Tapered Implant Multi-Unit Abutment 4.5 mmH - 5 Implant Glidewell HT Implant GL Titanium Abutment 4.5 mmH - 6 Implant Glidewell HT Implant Non-Engaging UCLA Gold - 6 Implant Glidewell HT Implant 17° Multi-Unit Abutment 3.5 mmH - 3.5/4.3 Implant Glidewell HT Implant Healing Abutment 7 mmH - 4.3 Implant Glidewell HT Implant Titanium Abutment Blank - 3 Implant Glidewell HT Implant GL Titanium Abutment 4.5 mmH - 5 Implant Hahn Tapered Implant Titanium Abutment 6 mmH - 3 Implant Hahn Tapered Implant Titanium Abutment 6 mmH - 3.5/4.3 Implant Hahn Tapered Implant GL Titanium Abutment 6 mmH - 7 Implant Hahn Tapered Implant 17 Multi-Unit Abutment 2.5 mmH - 3.5/4.3 Implant Hahn Tapered Implant Non-Engaging Titanium Abutment 4.5 mmH - 3 Implant Glidewell HT Implant 5 x 13 mm Glidewell HT Implant UCLA Gold - 3.5/4.3 Implant Hahn Tapered Implant Titanium Abutment 4.5 mmH - 3.5/4.3 Implant Hahn Tapered Implant Multi-Unit Abutment 2.5 mmH - 5 Implant Hahn Tapered Implant 5 x 10 mm Hahn Tapered Implant 4.3 x 10 mm Hahn Tapered Implant Non-Engaging Titanium Abutment 4.5 mmH - 3.5/4.3 Implant Hahn Tapered Implant GL Titanium Abutment 4.5 mmH - 3 Implant Glidewell HT Implant 5 x 10 mm Glidewell HT Implant GL Titanium Abutment 6 mmH - 3 Implant Glidewell HT Implant 3 x 11.5 mm Glidewell HT Implant Titanium Abutment 6 mmH - 6 Implant Hahn Tapered Implant Guide Pin - 3 Implant Hahn Tapered Implant Angled Multi-Unit Abutment Screw - 3.5/4.3 Implant Hahn Tapered Implant Anterior Esthetic Abutment - 3 Implant Hahn Tapered Implant Titanium Abutment 6 mmH - 5 Implant Glidewell HT Implant Non-Engaging Temporary Abutment - 3.5/4.3 Implant Hahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 3 Implant Hahn Tapered Implant Non-Engaging Temporary Abutment - 7 Implant Hahn Tapered Implant Healing Abutment 5 mmH - 3.5 Implant Hahn Tapered Implant 3 x 13 mm Hahn Tapered Implant 3.5 x 11.5 mm Glidewell HT Implant GL Titanium Abutment 4.5 mmH - 3.5/4.3 Implant Glidewell HT Implant 15° Anterior Esthetic Abutment - 3 Implant Glidewell HT Implant Titanium Abutment 6 mmH - 3 Implant Hahn Tapered Implant 4.3 x 8 mm Hahn Tapered Implant Multi-Unit Abutment 3.5 mmH - 3.5/4.3 Implant Hahn Tapered Implant GL Titanium Abutment 4.5 mmH - 3.5/4.3 Implant Glidewell HT Implant Temporary Abutment - 5 Implant Glidewell HT Implant Multi-Unit Abutment 2.5 mmH - 5 Implant Hahn Tapered Implant 7 x 10 mm Hahn Tapered Implant Titanium Abutment 4.5 mmH - 7 Implant Hahn Tapered Implant Titanium Screw - 3 Implant (5-pack) Hahn Tapered Implant 3.5 x 8 mm Hahn Tapered Implant Titanium Abutment 6 mmH - 7 Implant Hahn Tapered Implant Guide Pin - 3 Implant (5-pack) Glidewell HT Implant 5 x 16 mm Glidewell HT Implant Titanium Abutment 6 mmH - 3.5/4.3 Implant Glidewell HT Implant Anterior Esthetic Abutment - 5 Implant Hahn Tapered Implant Healing Abutment 7 mmH - 4.3 Implant Hahn Tapered Implant Multi-Unit Abutment 1.5 mmH - 3.5/4.3 Implant Hahn Tapered Implant UCLA Gold - 3 Implant Hahn Tapered Implant GL Titanium Abutment 6 mmH - 3 Implant Hahn Tapered Implant Non-Engaging Titanium Abutment 4.5 mmH - 3.5/4.3 Implant Hahn Tapered Implant Angled Multi-Unit Abutment Screw - 5 Implant Hahn Tapered Implant Healing Abutment 5 mmH - 7 Implant Hahn Tapered Implant Healing Abutment 5 mmH - 5 Implant Hahn Tapered Implant 15 Anterior Esthetic Abutment - 3 Implant Glidewell HT Implant 5 x 11.5 mm Glidewell HT Implant Non-Engaging Temporary Abutment - 7 Implant Glidewell HT Implant Posterior Esthetic Abutment - 7 Implant Glidewell HT Implant Temporary Abutment - 7 Implant Glidewell HT Implant Multi-Unit Abutment 2.5 mmH - 3.5/4.3 Implant Hahn Tapered Implant 5 x 11.5 mm Hahn Tapered Implant Non-Engaging UCLA Gold - 3 Implant Hahn Tapered Implant Titanium Abutment Blank - 7 Implant Hahn Tapered Implant 17 Multi-Unit Abutment 2.5 mmH - 5 Implant Glidewell HT Implant Multi-Unit Abutment 1.5 mmH - 3.5/4.3 Implant Glidewell HT Implant Anterior Esthetic Abutment - 3 Implant Glidewell HT Implant Healing Abutment 5 mmH - 7 Implant Hahn Tapered Implant GL Titanium Abutment 6 mmH - 3.5/4.3 Implant Hahn Tapered Implant Non-Engaging Temporary Abutment - 5 Implant Hahn Tapered Implant Healing Abutment 7 mmH - 3.5 Implant Glidewell HT Implant Healing Abutment 5 mmH - 4.3 Implant Glidewell HT Implant 3.5 x 11.5 mm Glidewell HT Implant Non-Engaging UCLA Gold - 7 Implant Glidewell HT Implant 7 x 11.5 mm Glidewell HT Implant Titanium Abutment 4.5 mmH - 5 Implant Glidewell HT Implant UCLA Gold - 6 Implant Hahn Tapered Implant Healing Abutment 7 mmH - 5 Implant Hahn Tapered Implant Titanium Screw - 3.5/4.3 Implant Glidewell HT Implant 3.5 x 13 mm Glidewell HT Implant Anterior Esthetic Abutment - 3.5/4.3 Implant Glidewell HT Implant Multi-Unit Abutment 4.5 mmH - 5 Implant Hahn Tapered Implant Non-Engaging Temporary Abutment - 5 Implant Hahn Tapered Implant Temporary Abutment - 3.5/4.3 Implant Hahn Tapered Implant Angled Multi-Unit Abutment Screw - 5 Implant Glidewell HT Implant 3 x 13 mm Glidewell HT Implant GL Titanium Abutment 4.5 mmH - 7 Implant

Establishment Types

Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device