Surgical Guide, STD Abutment Insertion Guide IFU

INSTRUCTIONS FOR USE (IFU) - Australia Patient Matched Medical Device (PMMD)

Device Family: Surgical Guide, STD Abutment Insertion Guide

GMDN: 57949

Product Code(s): SAIG

Manufacturer:

Zima International, Inc. Also DBA Dandy

1320 N. 300 W.

Lehi, UT 84043

United States

Contact: 

Australian Sponsor

Name = DANDY Labs AUS Pty Ltd

Registered Address = Tower One - International Towers, Level 46, 100 Barangaroo Avenue, Sydney, New South Wales 2000 Australia 

Intended User: Prescriber Dental professional / dental practice

Device Type: Patient Matched Medical Device (PMMD)

Sterility: Not supplied sterile (if applicable)

Single-use / Reusable: Single-use

1) Intended Purpose (Intended Use)

The Insertion Guide is intended for use with single or multiple abutments during placement. It is intended for short-term use and is then discarded.

2) Device Description / Key Specifications

- Custom-made, patient-specific device manufactured per dental professional prescription and digital input data.

- Configuration: Abutment placement on a dental implant or on multiple implants in the correct orientation, performed by a dental professional.

- Material: Acrylic - monomer and powder

Lucitone 199

Monomer

Powder

3) Contraindications

Allergy to or hypersensitivity to the used materials

4) Warnings / Precautions / Potential Risks

Warning 

Surgery in the oral cavity and oral rehabilitation include general risks. 

These include (but are not limited to):

• Small components accidentally dropped in the patient’s mouth can be swallowed or aspirated.
• Allergy or hypersensitivity to the chemical ingredients of the material used.

Precautions 

• The Abutment Insertion Guide should not be exposed to thermal treatment such as steam or dry heat sterilization.
• This product is intended for single use and may not be reused.  Reusing the product introduces:
• The risk of infection and complications due to a loss of accuracy of fit and the precision of the components.
• Performance failure of the device.
• Infection, inflammation, or allergy related to the device.
• Swallowing or inhalation of the device or a part thereof.

5) Cleaning and Care (Patient Care Instructions — as directed by the dental professional)

Do not autoclave or use dry heat sterilization as these may affect the mechanical properties.  Chemical disinfection is recommended before use.  

E.g.. Cidex OPA Solution - 0.55% ortho-phthaldehyde

Use

1. Check the osseointegration of the implant/implants to be restored
2. Try in the Insertion Guide
3. Before placing the abutment/abutments, try the guide in the patient’s mouth.  Ensure a tight fit and a secure fit.
4. Placement of the abutment in the guide
5. Place the abutment/abutments in the insertion guide and ensure proper fit and orientation (timing). There should be a slight resistance while inserting the abutment /abutments into the guide, and it should hold them securely.
6. Abutment insertion
7. Make sure to hold the guide gently.
8. Place the guide on the patient’s teeth and seat it in place.
9. Each abutment should adapt to the implant’s orientation.
10. Insert each abutment/abutment into the appropriate implant.
11. If resistance is felt, ensure abutment/abutments are aligned with the implant.
12. Abutment Screw Tightening
13. While holding the guide in place, insert the Abutment Screw (should be located in the model) and tighten.
14. Take a radiograph to confirm seating.
15. Final tightening
16. Tighten the abutment screw using a torque wrench according to the implant manufacturer’s torque specifications.
17. If the soft tissue creates hard resistance and blanches during seating, it is recommended that you proceed slowly before final torquing of the screw.
18. Cover the screw head
    1. Use your preferred method.
    2. Dandy recommends:
       1. Either a material similar to plumber’s tape or a cotton pellet.
19. Then cover with a material similar to Cavit.
20. Cementation
    1. Cement the final restoration to the abutment using your preferred method (make sure that the cement method is consistent with the restoration type).

6) Storage

The products should be stored in their packaging in a dry place at a normal temperature

(18–25°C/64–77°F). Use the sterilized components within the stated time period from the sterile bag.

7) Expected Life / Service

The dental abutment placement guide itself is a single-use or short-term tool for precise implant placement

8) Incident / Complaint Reporting (UK)

Report suspected serious incidents associated with this device to:

- The Manufacturer and/or UK Responsible Person (UKRP) using the contacts above, and

- The UK Medicines and Healthcare products Regulatory Agency (MHRA) in accordance with local requirements.

9) Disposal

Comply with the current applicable national waste disposal regulations.

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