Surgical
Guide

Contents

The procedures described in this document provide essential information to perform the surgical and prosthetic techniques of the ZiNova one-piece implant. This guide does not replace the user instructions. Please read the user instructions before using the products.

Characteristics of the
One-piece implant family

The micro and macro roughnesses on the ZiNova 3D Native implant surface (3D-N) allow for successful osseointegration following implantation.

Characteristics of
the implant design

ABUTMENT COMPATIBLE WITH DIGITAL AND ANALOG IMPRESSIONS

ABUTMENT SURFACE (Ra 1.4–2.5 µm) FOR MECHANICAL RETENTION FOR CEMENTATION

SMOOTH SURFACE FOR SOFT TISSUES (Ra <1 µm)

IMPLANTABLE SURFACE (Ra 1.4–2.5 µm)

VARIABLE THREAD PITCH

TAPERED BODY DESIGN WITH SELF-TAPPING THREADS

Surgical Procedure

1. Surgical Planning

The diameter, implant type, position and number of implants should be selected individually, taking the anatomy and spatial circumstances into account. Prosthetic-driven planning is recommended.

Implant Positioning

To plan implant positioning, the following three basic rules must be followed.

1

The minimum distance from the implant shoulder to the adjacent tooth at bone level (mesial and distal) is ≥1.5 mm.

2

The recommended minimum distance between adjacent implant shoulders at bone level is ≥3 mm.

3

Pay special attention to optimal positioning of the one-piece implant.

No angular correction of the abutments is allowed, nor should the implant body be placed at an angle; implants must be parallel to the direction of occlusal loading forces.

2. Preparation of the surgical bed

The preparation of the surgical bed is accomplished with the ZiNova Implants Surgical Kit.

2.1 Surgical instruments

The kit cassette has two levels for items to be sterilized: surgical tools on the upper level and the torque wrench on the lower level.

2.2 Alignment Pin

The Alignment Pin is used during implant bed preparation to confirm positioning. It indicates direction and duplicates the implant neck and abutment. After the initial osteotomy with the Ø2 mm twist drill, place the pin to confirm angulation, implant depth and restorative margin position.

3. Osteotomy

ZiNova One-piece Implant Ø3.7 mm

Step	Instrument	Ø	RPM
1	Starter drill	—	<1200
2	Twist drill	2 mm	<800
3	Twist drill	2.5 mm	<800
4	Tapered drill	3.7 mm	<800
5*	Bone tap	3.7 mm	<20

ZiNova One-piece Implant Ø4.3 mm

Step	Instrument	Ø	RPM
1	Starter drill	—	<1200
2	Twist drill	2 mm	<800
3	Twist drill	2.5 mm	<800
4	Tapered drill	3.7 mm	<800
5	Tapered drill	4.3 mm	<800
6*	Bone tap	4.3 mm	<20

*Bone tap appropriate for high-density osseous tissue, such as bone type 1 and 2. Follow the sequence with irrigation and torque control below 45 N·cm.

4. Implant Insertion

4.1 Container

The container allows proper handling and maintains sterility. The sterile tray holds the implant upright in a ceramic implant holder; the implant does not contact the plastic tray.

The implant is supplied in a single sterile barrier packaging system.

4.2 Aseptic Transfer

Open the implant as close to the time of use as possible. Non-sterile personnel should open and hold the device at the edge of the sterile field. Scrubbed personnel use the Insert Handpiece to remove the implant from its holder. The handpiece couples to the implant top and is used for initial positioning. Once attached, transfer the implant into the sterile field.

4.3 Implant insertion instructions

Initiate placement with the Insert Handpiece for better control of angulation and position. The Insert Wrench can seat the implant to its final position and make fine adjustments. Placement may be manual or with a handpiece. Do not exceed 45 N·cm torque.

5. Prosthetic Procedure

The recommended healing period to achieve successful osseointegration should be no less than 12 weeks.

In some cases the clinician should determine the appropriate healing time based on bone density, primary stability, simultaneous bone grafting or other clinical situations.

After placement: protect the healing phase, deliver a provisional if indicated, take final impressions, then deliver the definitive prosthesis.

5.1 Healing

For delayed or traditional loading, use of a protective healing cap is recommended. It softens unwanted chewing forces, protects the implant, prevents mucosa covering the shoulder and aids formation of the prosthetic emergence profile.

The cap is manufactured from PEEK. Cement with provisional cement; once set, remove excess cement.

5.2 Provisional prosthesis preparation

If a provisional crown is planned, use the Temporary Abutment designed to fit the implant abutment for retention and seal.

Temporary Abutment: Ø3.7 CZA37-0; Ø4.3 CZA43-0.

5.3 Taking impressions

For analog impressions, use a closed-tray technique with a rigid tray. A digital impression using an FDA-cleared intraoral/lab scanner is also possible. Verify seating of the Impression Coping; implant analogs replicate the implant design.

5.4 Definitive restoration

Definitive restorations should be metal-free (zirconia, lithium disilicate, graphene, etc.). Laboratories may use conventional techniques. A digital impression can be taken with an FDA-cleared intraoral/lab scanner. For conventional impressions, a laboratory table scanner may import the data for fabrication.