Titanium Abutment with Shoulder for Implant H2.1

Titanium Abutment with Shoulder for Implant H2.1

Intended Use

The Titanium Abutment with Shoulder for Implant H2.1 is intended for use with compatible narrow platform dental implants to support cement-retained implant-supported restorations.

Contraindications

Do not use:

- With implant systems not listed in these instructions.
- If the component is damaged, deformed, or contaminated.
- In patients with conditions that contraindicate implant treatment.
- When compatibility with the implant system cannot be verified.
- In cases of insufficient implant stability or failed osseointegration.

Warnings

- This product is intended for use only by qualified dental professionals.
- Use only original compatible components and fixation screws.
- Failure to properly seat the abutment may result in mechanical complications, component loosening, or restoration failure.
- Improper prosthetic procedures may compromise the fit, function, and longevity of the restoration.
- The product is intended for single-patient use only.

Precautions

- Verify implant compatibility before use.
- Inspect the abutment and fixation screw prior to use.
- Confirm complete seating of the abutment before tightening the fixation screw.
- Verify proper fit clinically and radiographically.
- Ensure that the shoulder portion of the abutment is appropriately positioned relative to the soft tissue profile.
- Follow accepted clinical protocols for implant restoration and maintenance.
- Maintain traceability of the product lot number in patient records.

Instructions for Use

Clinical Procedure

1. Verify compatibility of the abutment with the selected implant system.
2. Remove the healing abutment or cover screw and thoroughly clean the implant connection.
3. Inspect the internal implant hex and ensure it is free of debris and contamination.
4. Seat the Titanium Abutment with Shoulder for Implant H2.1 into the implant connection and verify complete seating.
5. Secure the abutment using fixation screw 701203 and tighten according to the implant system protocol.
6. Verify the position and fit of the abutment clinically and radiographically.
7. Confirm proper shoulder positioning and soft tissue adaptation.
8. Fabricate or place the definitive cement-retained restoration.
9. Verify occlusion, stability, and restoration fit.
10. Remove all excess cement from the restoration margins.
11. Perform routine follow-up examinations according to accepted clinical protocols.

Sterilization

- The product is supplied non-sterile.
- Clean and sterilize the abutment using a validated steam sterilization cycle. 
- Autoclave sterilization at 135°C (274°F) is required prior to placement.
- Do not use the product if sterility cannot be assured.

Storage

Store in a clean, dry environment in the original packaging. Protect from contamination, excessive heat, direct sunlight, moisture, and mechanical damage.