(192 days)
VITA ENAMIC Implant Solutions is indicated for use as a component of a two-piece abutment system, consisting of a tibase component, and a mesostructure or abutment crown. VITA ENAMIC Implant Solutions is intended for use in partially or fully edentulous mandible or maxillae for fabrication of permanent, anterior or posterior, single unit CAD/CAM abutments. VITA ENAMIC Implant Solutions is indicated for use in conjunction with the CAD/CAM component of the Sirona Dental CAD/CAM system and the following Tibase abutments and implant bodies: (See Table 1 in document for list of compatible Ti Base/Implant Systems).
VITA ENAMIC Implant Solutions (IS) is a hybrid ceramic CAD/CAM block, consisting of ~86% (by weight) feldspar ceramic and ~14% polymer. The VITA ENAMIC Implant Solutions is milled then bonded to a titanium (Ti) base for a two-element solution with mesostructure or a single-element solution with abutment crown. The compatible Ti bases to VITA ENAMIC IS block interface size and CAD/CAM system are as follows: Ti Base: Sirona TiBase (K111421), CAD/CAM System: Sirona software – inlab 15.0 and above, Sirona software – CEREC 4.4 and above, Titanium Bases: Compatible titanium bases are shown in Table 1. VITA ENAMIC IS is offered in a block form, with a mandrel attachment, to permit securing it into a CAD/CAM machine for milling into its final form. The VITA ENAMIC IS blocks have a pre-drilled hole compatible with Sirona TiBase (K111421) to allow the mesostructure or abutment crown bonded to a titanium base to be connected to the implant. VITA ENAMIC IS blocks are identical to VITA ENAMIC blocks (K122269) in geometry, with the exception of a pre-drilled hole.
The document is a 510(k) premarket notification for a dental device, VITA ENAMIC® Implant Solutions (IS). It aims to demonstrate substantial equivalence to legally marketed predicate devices, not to establish new performance criteria. Therefore, the traditional concept of "acceptance criteria" and a "study to prove the device meets acceptance criteria" as might be seen for a novel AI device with specific performance metrics (e.g., sensitivity, specificity) does not directly apply in this context.
Instead, the submission demonstrates that the VITA ENAMIC IS device is substantially equivalent to existing predicate devices by showing it meets applicable recognized standards for dental materials and has comparable technical characteristics. The criteria for acceptance in this regulatory context are based on a comparison to the predicate devices.
Here's a breakdown of the information requested, adapted to the context of this 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, for a 510(k) submission, "acceptance criteria" are typically the demonstrated equivalence to predicate devices and compliance with recognized standards. The "reported device performance" is how the VITA ENAMIC IS compares to these predicates and standards.
| Acceptance Criterion (Regulatory/Standard Compliance) | Reported Device Performance (VITA ENAMIC IS) |
|---|---|
| Indications for Use (similar to predicates) | "non-identical, but similar indications as the inCoris Zl meso and IPS e.max CAD Abutment Solutions" and "...intended use for each is similar." |
| Biocompatibility (per ISO 10933-1:2009 & ISO 7405:2008) | "biocompatible and concludes that the device is compatible for its intended use" (leveraged testing from VITA ENAMIC K122269) |
| Ceramic materials standard (ISO 6872:2008) | Meets applicable requirements. |
| Polymer-based crown and bridge materials standard (ISO 10477:2004(E)) | Meets applicable requirements. |
| Dynamic fatigue test for endosseous dental implants (ISO 14801:2007) | Meets applicable requirements. Bench test results conclude it is "well suited for its intended use." |
| Chemical Composition (identical to VITA ENAMIC K122269) | Identical chemical composition to VITA ENAMIC (K122269). Consists of ~86% feldspar ceramic and ~14% polymer. |
| Physical Properties (identical to VITA ENAMIC K122269) | Identical physical properties to VITA ENAMIC (K122269). |
| Flexural Strength (for comparison, not an explicit "acceptance criteron" value) | 140 ± 10 MPa (Comparable to VITA ENAMIC, lower than inCoris ZI meso (> 900 MPa) and IPS e.max CAD Abutment Solutions (360 ± 60 MPa) due to material type). |
| Fracture Toughness (for comparison) | 1.5 MPa m0.5 (Comparable to VITA ENAMIC, lower than inCoris ZI meso (5.9 Mpa m0.5) and IPS e.max CAD Abutment Solutions (2.0 – 2.5 MPa m0.5)). |
| Young's Modulus of Elasticity (for comparison) | 30 GPa (Comparable to VITA ENAMIC, lower than IPS e.max CAD Abutment Solutions (95 ± 5 GPa)). |
| Abutment Angulation (comparable to predicates) | Maximal Abutment Angulation: 20° (same as inCoris Zl meso and IPS e.max CAD Abutment Solutions). |
2. Sample size used for the test set and data provenance
The document refers to "Bench test results" and states that "No human clinical testing was performed." The testing appears to be primarily material and mechanical property testing following ISO standards. The specific sample sizes for these bench tests are not provided in this document. The data provenance is implied to be internal testing by the manufacturer (Vita Zahnfabrik H.Rauter GmbH Co.), likely conducted in Germany, and is retrospective for the purpose of this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to a 510(k) submission for a dental implant abutment material, which relies on objective material property testing against recognized standards rather than expert-derived ground truth.
4. Adjudication method for the test set
Not applicable. The "test set" here refers to physical material and mechanical property tests, which yield objective measurements, not subjective evaluations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-powered diagnostic device, but a dental implant material. No MRMC studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is established by recognized ISO standards for dental materials and implant systems (e.g., ISO 6872, ISO 10477, ISO 14801) and by the existing performance characteristics of legally marketed predicate devices. The testing verifies that the device meets these established engineering and material benchmarks.
8. The sample size for the training set
Not applicable. There is no AI model or training set involved.
9. How the ground truth for the training set was established
Not applicable. There is no AI model or training set involved.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)