(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.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and unity. The profiles are rendered in a dark color, contrasting with the white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2016
Vita Zahnfabrik H. Rauter GmbH Co. % Ms. Nevine Erian Director, Regulatory Affairs & Compliance (consultant) Vita North America, Inc. 22705 Savi Ranch Parkway, Suite 100 Yorba Linda. California 92887
Re: K153645
Trade/Device Name: VITA ENAMIC® Implant Solutions (IS) Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 27, 2016 Received: June 3, 2016
Dear Ms. Erian:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name
VITA ENAMIC Implant Solutions (IS)
Indications for Use
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:
| Table 1 - Compatible Sirona Ti Base/Implant System and VITA ENAMIC IS Interface | ||||||
|---|---|---|---|---|---|---|
| SironaTiBase Type | AbutmentScrew | SironaPart # | VITA ENAMICIS Interface | ImplantManufacturer | Implant System | ImplantDiameter |
| NBRS 3.5 | M1.8 | 6282474 | L | Nobel Biocare | Replace® NP | 3.5 mm |
| NBRS 4.3 | M2 | 6282482 | L | Nobel Biocare | Replace® RP | 4.3 mm |
| NBRS 5.0 | M2 | 6282490 | L | Nobel Biocare | Replace® WP | 5.0 mm |
| NBRS 6.0 | M2 | 6282508 | L | Nobel Biocare | Replace® 6.0 | 6.0 mm |
| NBB 3.4 | M1.6 | 6282516 | L | Nobel Biocare | Brånemark® | 3.3 mm |
| NBB 4.1 | M2 | 6282524 | L | Nobel Biocare | Brånemark® | 3.75 / 4.0 mm |
| NB A 4.5 | M1.6 | 6308188 | L | Nobel Biocare | Nobel Active NP | 3.5 mm |
| NB A 5.0 | M2 | 6308253 | L | Nobel Biocare | Nobel Active RP | 4.3 / 5.0 mm |
| SSO 3.5 | M1.8 | 6284231 | L | Straumann® | Tissue level NN | 3.5 mm |
| SSO 4.8 | M2 | 6284249 | L | Straumann® | Tissue Level RN | 4.8 mm |
| SSO 6.5 | M2 | 6284256 | L | Straumann® | Tissue Level WN | 6.5 mm |
| S BL 3.3 | M1.6 | 6308154 | L | Straumann® | Bone Level NC | 3.3mm |
| S BL 4.1 | M1.6 | 6308337 | L | Straumann® | Bone Level NC | 4.1 / 4.8 mm |
| ATOS 3.5/4.0 | M1.6 | 6282532 | L | Astra Tech | OsseoSpeed™ | 3.5 S/4.0 S mm |
| ATOS 4.5/5.0 | M1.6 | 6282540 | L | Astra Tech | OsseoSpeed™ | 4.5 / 5.0 mm |
| FX 3.4 | M1.6 | 6282433 | S | Friadent | Frialit®Xive® | 3.4 mm |
| FX 3.8 | M1.6 | 6282441 | S | Friadent | Frialit®Xive® | 3.8 mm |
| FX 4.5 | M1.6 | 6282458 | L | Friadent | Frialit®Xive® | 4.5 mm |
| FX 5.5 | M1.6 | 6282466 | L | Friadent | Frialit®Xive® | 5.5 mm |
| BO 3.4 | M2 | 6282557 | L | Biomet 3i | Ex. hex | 3.4 mm |
| BO 4.1 | M2 | 6282565 | L | Biomet 3i | Ex. hex | 4.1 mm |
| BO 5.0 | M2 | 6282573 | L | Biomet 3i | Ex. hex | 5.0 mm |
| B C 3.4 | M1.6 | 6308048 | S | Biomet 3i | Certain® | 3.5 mm |
| B C 4.1 | M1.6 | 6308097 | L | Biomet 3i | Certain® | 4.5 mm |
| B C 5.0 | M1.6 | 6308121 | L | Biomet 3i | Certain® | 5.7 mm |
{3}------------------------------------------------
| Table 1 – Compatible Sirona Ti Base/Implant System and VITA ENAMIC IS Interface | ||||||
|---|---|---|---|---|---|---|
| SironaTiBase Type | AbutmentScrew | SironaPart # | VITA ENAMICIS Interface | ImplantManufacturer | Implant System | ImplantDiameter |
| ZTSV 3.5 | M1.8 | 6282581 | L | Zimmer | Tapered screw-Vent® | 3.5 mm |
| ZTSV 4.5 | M1.8 | 6282599 | L | Zimmer | Tapered screw-Vent® | 4.5 mm |
| ZTSV 5.7 | M1.8 | 6282607 | L | Zimmer | Tapered screw-Vent® | 5.7 mm |
Prescription Use _____X (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON SEPARATE PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{4}------------------------------------------------
K153645 510(k) Summary
| Submitter | Vita Zahnfabrik H.Rauter GmbH Co.Spitelgasse 3Bad Sackingen, D-79713GermanyEstablishment Reg. No. 1000625496 |
|---|---|
| Contact | Bernd WalkerHead of Regulatory Affairs and Quality SystemsPhone (+49) 7761/562-361Fax (+49) 7761/562-384 |
| Official Correspondent | Nevine ErianDirector, Regulatory Affairs & Compliance (Consultant)VITA North America, Inc.22705 Savi Ranch Parkway, Suite 100Yorba Linda, CA 92887Establishment Reg. No. 2082832Phone (949) 370-7155Fax (714) 221-6759E-mail: nerian@vident.com |
| Date Prepared | June 30, 2016 |
| Trade/Device Name■ | VITA ENAMIC® Implant Solutions (IS) |
| ■Common Name | Abutment, implant, dental, endosseous |
- Classification Name Endosseous Dental Implant Abutment
- Regulation Number 21 CFR 872.3630
- . Product Code NHA
Predicate Devices
inCoris ZI meso (Sirona Dental) – K111421 – Primary Predicate VITA ENAMIC® (VITA Zahnfabrik GmbH) – K122269 IPS e.max® CAD Abutment Solutions (Ivoclar Vivadent) – K132209
{5}------------------------------------------------
Device Description
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 aboveSirona software – CEREC 4.4 and above |
| Titanium Bases: | Compatible titanium bases are shown in Table 1 |
| Table 1 - Compatible Sirona Ti Base/Implant System and VITA ENAMIC IS Interface | ||||||
|---|---|---|---|---|---|---|
| SironaTiBase Type | AbutmentScrew | SironaPart # | VITA ENAMICIS Interface | ImplantManufacturer | Implant System | ImplantDiameter |
| NBRS 3.5 | M1.8 | 6282474 | L | Nobel Biocare | Replace® NP | 3.5 mm |
| NBRS 4.3 | M2 | 6282482 | L | Nobel Biocare | Replace® RP | 4.3 mm |
| NBRS 5.0 | M2 | 6282490 | L | Nobel Biocare | Replace® WP | 5.0 mm |
| NBRS 6.0 | M2 | 6282508 | L | Nobel Biocare | Replace® 6.0 | 6.0 mm |
| NBB 3.4 | M1.6 | 6282516 | L | Nobel Biocare | Brånemark® | 3.3 mm |
| NBB 4.1 | M2 | 6282524 | L | Nobel Biocare | Brånemark® | 3.75 / 4.0 mm |
| NB A 4.5 | M1.6 | 6308188 | L | Nobel Biocare | Nobel Active NP | 3.5 mm |
| NB A 5.0 | M2 | 6308253 | L | Nobel Biocare | Nobel Active RP | 4.3 / 5.0 mm |
| SSO 3.5 | M1.8 | 6284231 | L | Straumann® | Tissue level NN | 3.5 mm |
| SSO 4.8 | M2 | 6284249 | L | Straumann® | Tissue Level RN | 4.8 mm |
| SSO 6.5 | M2 | 6284256 | L | Straumann® | Tissue Level WN | 6.5 mm |
| S BL 3.3 | M1.6 | 6308154 | L | Straumann® | Bone Level NC | 3.3mm |
| S BL 4.1 | M1.6 | 6308337 | L | Straumann® | Bone Level NC | 4.1 / 4.8 mm |
| ATOS 3.5/4.0 | M1.6 | 6282532 | L | Astra Tech | OsseoSpeed™ | 3.5 S/4.0 S mm |
| ATOS 4.5/5.0 | M1.6 | 6282540 | L | Astra Tech | OsseoSpeed™ | 4.5 / 5.0 mm |
| FX 3.4 | M1.6 | 6282433 | S | Friadent | Frialit®Xive® | 3.4 mm |
| FX 3.8 | M1.6 | 6282441 | S | Friadent | Frialit®Xive® | 3.8 mm |
| FX 4.5 | M1.6 | 6282458 | L | Friadent | Frialit®Xive® | 4.5 mm |
| FX 5.5 | M1.6 | 6282466 | L | Friadent | Frialit®Xive® | 5.5 mm |
| BO 3.4 | M2 | 6282557 | L | Biomet 3i | Ex. hex | 3.4 mm |
| BO 4.1 | M2 | 6282565 | L | Biomet 3i | Ex. hex | 4.1 mm |
| BO 5.0 | M2 | 6282573 | L | Biomet 3i | Ex. hex | 5.0 mm |
| B C 3.4 | M1.6 | 6308048 | S | Biomet 3i | Certain® | 3.5 mm |
| B C 4.1 | M1.6 | 6308097 | L | Biomet 3i | Certain® | 4.5 mm |
| B C 5.0 | M1.6 | 6308121 | L | Biomet 3i | Certain® | 5.7 mm |
| ZTSV 3.5 | M1.8 | 6282581 | L | Zimmer | Tapered screw-Vent® | 3.5 mm |
| ZTSV 4.5 | M1.8 | 6282599 | L | Zimmer | Tapered screw-Vent® | 4.5 mm |
| ZTSV 5.7 | M1.8 | 6282607 | L | Zimmer | Tapered screw-Vent® | 5.7 mm |
{6}------------------------------------------------
Statement of Intended Use
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:
| Table 1 - Compatible Sirona Ti Base/Implant System and VITA ENAMIC IS Interface | ||||||
|---|---|---|---|---|---|---|
| SironaTiBase Type | AbutmentScrew | SironaPart # | VITA ENAMICIS Interface | ImplantManufacturer | Implant System | ImplantDiameter |
| NBRS 3.5 | M1.8 | 6282474 | L | Nobel Biocare | Replace® NP | 3.5 mm |
| NBRS 4.3 | M2 | 6282482 | L | Nobel Biocare | Replace® RP | 4.3 mm |
| NBRS 5.0 | M2 | 6282490 | L | Nobel Biocare | Replace® WP | 5.0 mm |
| NBRS 6.0 | M2 | 6282508 | L | Nobel Biocare | Replace® 6.0 | 6.0 mm |
| NBB 3.4 | M1.6 | 6282516 | L | Nobel Biocare | Brånemark® | 3.3 mm |
| NBB 4.1 | M2 | 6282524 | L | Nobel Biocare | Brånemark® | 3.75 / 4.0 mm |
| NB A 4.5 | M1.6 | 6308188 | L | Nobel Biocare | Nobel Active NP | 3.5 mm |
| NB A 5.0 | M2 | 6308253 | L | Nobel Biocare | Nobel Active RP | 4.3 / 5.0 mm |
| SSO 3.5 | M1.8 | 6284231 | L | Straumann® | Tissue level NN | 3.5 mm |
| SSO 4.8 | M2 | 6284249 | L | Straumann® | Tissue Level RN | 4.8 mm |
| SSO 6.5 | M2 | 6284256 | L | Straumann® | Tissue Level WN | 6.5 mm |
| S BL 3.3 | M1.6 | 6308154 | L | Straumann® | Bone Level NC | 3.3mm |
| S BL 4.1 | M1.6 | 6308337 | L | Straumann® | Bone Level NC | 4.1 / 4.8 mm |
| ATOS 3.5/4.0 | M1.6 | 6282532 | L | Astra Tech | OsseoSpeed™ | 3.5 S/4.0 S mm |
| ATOS 4.5/5.0 | M1.6 | 6282540 | L | Astra Tech | OsseoSpeed™ | 4.5 / 5.0 mm |
| FX 3.4 | M1.6 | 6282433 | S | Friadent | Frialit®Xive® | 3.4 mm |
| FX 3.8 | M1.6 | 6282441 | S | Friadent | Frialit®Xive® | 3.8 mm |
| FX 4.5 | M1.6 | 6282458 | L | Friadent | Frialit®Xive® | 4.5 mm |
| FX 5.5 | M1.6 | 6282466 | L | Friadent | Frialit®Xive® | 5.5 mm |
| BO 3.4 | M2 | 6282557 | L | Biomet 3i | Ex. hex | 3.4 mm |
| BO 4.1 | M2 | 6282565 | L | Biomet 3i | Ex. hex | 4.1 mm |
| BO 5.0 | M2 | 6282573 | L | Biomet 3i | Ex. hex | 5.0 mm |
| B C 3.4 | M1.6 | 6308048 | S | Biomet 3i | Certain® | 3.5 mm |
| B C 4.1 | M1.6 | 6308097 | L | Biomet 3i | Certain® | 4.5 mm |
| B C 5.0 | M1.6 | 6308121 | L | Biomet 3i | Certain® | 5.7 mm |
| ZTSV 3.5 | M1.8 | 6282581 | L | Zimmer | Tapered screw-Vent® | 3.5 mm |
| ZTSV 4.5 | M1.8 | 6282599 | L | Zimmer | Tapered screw-Vent® | 4.5 mm |
| ZTSV 5.7 | M1.8 | 6282607 | L | Zimmer | Tapered screw-Vent® | 5.7 mm |
{7}------------------------------------------------
Material Composition
VITA ENAMIC IS is identical in composition to VITA ENAMIC (K122269).
Technological Characteristics
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.
Because the subject device and its predicates inCoris Zl meso, IPS e.max CAD Abutment Solutions do not share similar chemical or physical properties, a reference device, VITA Enamic, was introduced by the sponsor. The differences between VITA ENAMIC IS and the predicate devices do not render the subject device not substantially equivalent for the following reasons:
- ı VITA ENAMIC IS has non-identical, but similar indications as the inCoris Zl meso and IPS e.max CAD Abutment Solutions, and meets the same biocompatibility, ISO 6872:2008 and ISO 14801:2007 test criteria. While the verbiage of the indications for use statements differs, the intended use for each is similar. All three are restorative blocks intended to serve as milled components of dental implant abutments and abutment crowns, and all three share implant compatibilities with the same Sirona TiBase devices.
- . VITA ENAMIC IS has the identical chemical composition and physical properties as VITA ENAMIC.
As such, the data supports the substantial equivalence of the subject and predicate devices.
Non-Clinical Performance Testing
VITA ENAMIC IS meets the applicable requirements of the following FDA recognized standards:
- . ISO 6872:2008 – Dentistry – Ceramic materials
- . ISO 10477:2004(E) - Dentistry - Polymer-based crown and bridge materials standard.
{8}------------------------------------------------
- I ISO 14801:2007 - Dentistry - Implants - Dynamic fatigue test for endosseous dental implants
Bench test results allowed us to conclude that VITA ENAMIC IS is well suited for its intended use.
Biocompatibility
A biocompatibility assessment was performed on VITA ENAMIC IS in accordance with ISO 10933-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process, and ISO 7405:2008 – Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry. Testing from reference device VITA ENAMIC was leveraged to support biocompatibility. This assessment supports that VITA ENAMIC IS is biocompatible and concludes that the device is compatible for its intended use.
Clinical Performance Data
Not applicable. No human clinical testing was performed to support the substantial equivalence of VITA ENAMIC IS.
Substantial Equivalence
Material
VITA ENAMIC IS has the identical chemical composition as the predicate device, VITA ENAMIC (K122269).
Physical Properties
VITA ENAMIC IS has identical physical properties as the predicate device, VITA ENAMIC (K122269).
| TechnicalAttributes | VITAENAMIC IS | inCoris Zl meso | IPS e.max CADAbutment Solutions | VITAENAMIC |
|---|---|---|---|---|
| Indication | Implant Abutmentand AbutmentCrown | Implant Abutmentand AbutmentCrown | Implant Abutment andAbutment Crown | Crown & Veneers |
| CAD/CAMMaterial | Yes | Yes | Yes | Yes |
| PhysicalConfiguration | Block with a pre-drilled hole andmandrel attachment | Block with a pre-drilled hole andmandrel attachment | Block with a pre-drilledhole and mandrelattachment | Block with mandrelattachment |
Technical Comparison of VITA ENAMIC IS to Predicate Devices
{9}------------------------------------------------
| TechnicalAttributes | VITAENAMIC IS | inCoris ZI meso | IPS e.max CADAbutment Solutions | VITAENAMIC |
|---|---|---|---|---|
| Block Sizes | 12 x 14 x 18 mm and18 x 16 x 18 mmwith Small or Largehole size | One block size withSmall or Large holesize | 12.4 x 14.5 x 18.0 mmand17.8 x 15.8 x 18.0 mmwith Small or Large holesize | 12 x 14 x 18 mm and8 x 10 x 15 mmwith Small or Largehole size |
| Shades &Translucency | Different shadesTranslucent &High Translucent | Two shades | Different shadesMedium Opacity & LowTranslucency | Different shadesTranslucent &High Translucent |
| Bonds toTitanium Base | Sirona TiBase withSmall & Large hole | Sirona TiBase withSmall & Large hole | Sirona TiBase with Small& Large hole | No |
| MaximalAbutmentAngulation | 20° | 20° | 20° | Not applicable |
| AbutmentFixation | Screwed | Screwed | Screwed | Not applicable |
| Screw | Part of implantsystem | Part of implantsystem | Part of implant system | Not applicable |
| CompatibleTitanium Base | Sirona TiBase(K11142) | Sirona TiBase(K11142) | Sirona TiBase(K11142) | Not applicable |
| 1 or 2 pieceAbutment | 2 piece — ENAMICIS to TiBase | 2 piece — Incoris ZIto TiBase | 2 piece - IPS e.maxCAD to TiBase | Not applicable |
| MechanicalTesting | Dynamic FatigueTesting per ISO14801 | Dynamic FatigueTesting per ISO14801 | Dynamic FatigueTesting per ISO 14801 | Not applicable |
| FlexuralStrength | 140 ± 10 MPa | > 900 MPa | 360 ± 60 MPa | 140 ± 10 MPa |
| FractureToughness | 1.5 MPa m0.5 | 5.9 Mpa m0.5 | 2.0 – 2.5 MPa m0.5 | 1.5 MPa m0.5 |
| Young'sModulus ofElasticity | 30 GPa | Unknown | 95 ± 5 GPa | 30 GPa |
Conclusion
Information provided by VITA North America, Inc. demonstrates that VITA ENAMIC Implant Solutions is substantially equivalent to the predicate devices. VITA ENAMIC IS shares the same indications and similar physical properties as the nCoris ZI meso and IPS e.max CAD Abutment Solutions. VITA ENAMIC IS has identical chemical composition and physical properties as VITA ENAMIC. - Comparisons of the indications for use, chemical composition, technological characteristics and physical properties of VITA ENAMIC IS to the predicate devices all support the substantial equivalence of VITA ENAMIC Implant Solutions to its predicate devices.
§ 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.)