PLASTIC PROTECTION HEALING CAPS
Device Facts
| Record ID | K962023 |
|---|---|
| Device Name | PLASTIC PROTECTION HEALING CAPS |
| Applicant | The Straumann Co. |
| Product Code | DZE · Dental |
| Decision Date | Aug 15, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
Intended Use
The intended use of the ITI Protection Healing Caps is to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the prosthetic phase to achieve an esthetic result with the final restoration. The primary indication for the Protection Healing Cap is in the esthetic zone of the oral cavity where soft tissue conditioning is essential to achieve an optimal esthetic result with implant-borne restorations.
Device Story
ITI Protection Healing Cap is a dental accessory mounted onto an abutment after placement into an implant. Used in the esthetic zone of the oral cavity; clinician modifies the cap using a sandpaper disc to maintain and condition soft tissue contours during the prosthetic phase. Device remains in place for approximately 2 weeks while the final restoration is constructed. Secured via occlusal screw tightened to 50 Ncm. Removed and disposed at final prosthesis delivery. Benefits patient by facilitating optimal esthetic outcomes for implant-borne restorations.
Clinical Evidence
Bench testing only.
Technological Characteristics
Material: Polyetheretherketone (PEEK). Form factor: Cylindrical cap with 65° bevel. Dimensions: 5.8 mm diameter/4.0 mm height or 6.2 mm diameter/5.0 mm height. Fixation: Occlusal screw (50 Ncm torque).
Indications for Use
Indicated for patients requiring soft tissue conditioning in the esthetic zone of the oral cavity during the prosthetic phase of dental implant restoration.
Regulatory Classification
Identification
An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
Predicate Devices
- Nobelpharma's Brånemark System Healing Caps (K925780)
- Calcitek's Abutment Comfort Caps
- Interpore International's Abutment Complete Sealing Caps (K912734)
- Steri-Oss' Healing Cap
Related Devices
- K960634 — TITANIUM HEALING CAPS · The Straumann Co. · Jun 18, 1996
- K171142 — Healing Cap Multi-Unit Titanium · Nobel Biocare AB · Oct 26, 2017
- K190654 — Straumann CI RD Ceramic Healing Caps · Institut Straumann AG · Jun 28, 2019
- K053643 — STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 · Lifecore Biomedical, Inc. · Jan 23, 2006
- K020096 — ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM · Institut Straumann AG · Feb 8, 2002
