(198 days)
Fabrication of single crowns for the anterior maxilla and mandible where exceptional esthetics are required.
The FRIALIT-2® CeraBase abutment is a two part abulment. It consists of the titanium insert and the caramic sleeve. The titanium insert has as the rotational securing device a hexagon. which is the counterpart to the internal hexagon of the FRIALIT-2® implant. The ceramic sleeve is blaced on top of the titanium insert where it is rotationally secured by a slot and key connection. The titanium insert is color-coded in order to clearly differentlate the different diameters. The diameters of the FRIALIT-2® CeraBase abutments correspond to the FRIALIT-2® implant diameters. The following diameters are available: D3,8 mm, D4,5 mm, D5,5 mm and D6,5 mm. The FRIALIT-2® CaraBase titanium insert is manufactured out of pure titanium grade II material which is in accordance to ASTM F 67 'Standard Specification for Unalloyed Titanium for Surgical Implant Application'. The FRIALIT-209 CeraBase ceramic sleeve is manufactured out of medical grade aluminumdioxid ceramic which Is In accordance to ASTM F 603 'Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application'.
The provided text describes the FRIALIT-2® CeraBase abutment and compares it to a predicate device, the NobelBioCare CeraOne abutment, to demonstrate substantial equivalence for a 510(k) submission. This type of submission focuses on comparing a new device to an existing, legally marketed predicate device rather than conducting a full clinical study with specific acceptance criteria in the way a clinical trial for a new drug or novel medical device would.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, while standard for certain device evaluations, is not explicitly detailed or applicable in the provided 510(k) summary. This document is a summary demonstrating substantial equivalence based on technological characteristics and preclinical testing, not a report of a full clinical trial or a diagnostic algorithm validation.
However, I can extract the relevant information presented and explain why other points are not directly addressed by this document:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, "acceptance criteria" are implied by the comparison to the predicate device. The performance metrics are technological properties and preclinical testing results, demonstrating that the new device is "substantially the same" or performs at least as well as the predicate.
| Properties / Performance Metric | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (FRIALIT-2® CeraBase) |
|---|---|---|
| Al2O3 content | 99.0 weight-% (NobelBioCare CeraOne) | 99.6 weight-% |
| crystallogical phase | α-aluminumdioxide (NobelBioCare CeraOne) | α-aluminumdioxide |
| grain size parameters [µm] | d10: 0.9, d50: 2.2, d90: 3.8 (NobelBioCare CeraOne) | d10: 1.3, d50: 3.9, d90: 7.7 |
| static shear strength [lbs] | 74.5 lbs (NobelBioCare CeraOne) | 99.2 lbs |
| dynamic fatigue strength [lbs] | runout at 35 lbs (NobelBioCare CeraOne) | runout at 35 lbs |
Explanation: In a 510(k) submission, the "acceptance criteria" for performance are broadly to demonstrate that the new device is as safe and effective as a legally marketed predicate device. For technical characteristics, this often means demonstrating similar properties or improved performance where applicable. For static shear strength, the FRIALIT-2® CeraBase significantly exceeds the predicate, and for dynamic fatigue strength, it matches the predicate's "runout" performance. The ceramic properties (Al2O3 content, crystallogical phase, grain size) are presented for comparison to show fundamental similarity in material.
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes preclinical testing results, not a clinical test set in the sense of patient data. The "samples" would refer to test pieces or prototypes of the abutments used in mechanical testing.
- Sample Size for Test Set: Not explicitly stated as a numerical value for each test (e.g., how many abutments were tested for static shear strength or grain size). It's typical for such engineering tests to use a statistically sound number of samples, but the specific count is not in this summary.
- Data Provenance: The tests are preclinical, conducted by the manufacturer (FRIATEC AG, Germany). Thus, the "country of origin of the data" is Germany. It is not retrospective or prospective patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This point is not applicable to this type of submission. "Ground truth" established by experts typically refers to clinical diagnoses or pathological findings in a diagnostic device study. This document concerns the physical, mechanical, and material properties of an implant abutment, which are measured using objective laboratory methods and engineering standards, not clinical expert consensus.
4. Adjudication Method for the Test Set
This is not applicable for the reasons stated in point 3. Adjudication methods (like 2+1 or 3+1 consensus) are used to resolve discrepancies among expert opinions when establishing ground truth for diagnostic or prognostic tasks, which is not the nature of this pre-clinical engineering data.
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
This is not applicable. This submission is for a physical medical device (dental abutment), not a diagnostic algorithm or AI-assisted system for human readers. Therefore, an MRMC study and AI-related effect sizes are irrelevant to this document.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
This is not applicable for the same reasons as point 5. No algorithm is being submitted or evaluated.
7. The Type of Ground Truth Used
The "ground truth" here is based on objective engineering measurements and material science standards. For example:
- Al2O3 content: Measured using chemical analysis.
- Crystallographical phase: Determined by techniques like X-ray diffraction.
- Grain size parameters: Measured using microscopy and image analysis.
- Static shear strength and dynamic fatigue strength: Determined using standardized mechanical testing procedures (e.g., ISO, ASTM standards relevant to dental implants).
It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of an engineering evaluation for a physical device like this, which would be relevant for machine learning algorithms.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set.
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KG80630)
SEP 4 1998
9:46 AM ;Advanced BicResearch
Premarket Notification 510(k) Article Name: FRIALIT-2® CeraBase Abutment
Image /page/0/Picture/4 description: The image shows a logo with a triangular shape at the top. Below the triangle, there is some text, but it is too blurry to read clearly. The logo appears to be for a company or organization, but without being able to read the text, it is difficult to determine the specific nature of the entity.
XI. 510(k) Summary of Safety and Effectiveness
XI.1. Submitter Information
Submitter: Registration number: Address:
Contact Person:
Data Prepared:
Telephone:
Fax:
e-mail:
FRIATEC AG. Medical Technology Division 8681851 Stainzaugstrasse 68229 Mannheim / Germany Birgit Unger (QA/RA Manager) 011-49-621-486-1549 011-49-621-486-1856 birgit_unger@friatec.de February 2nd, 1998
XI.2. Name of Device
FRIALIT-2® CeraBase abutment Proprietary Name: Ceramic abutment for endosseous implants Common Name: Classification Name: Endosseous implants
XI.3. Predicate Device Information
| Name: | CeraOne Abutment |
|---|---|
| Submitter: | NobelBioCare USA.Inc |
| 510(k) Number. | K961737 |
XI.4. Description of the Device
The FRIALIT-26 CeraBase abutment is a two part abulment. It consists of the titanium insert and the caramic sleeve. The titanium insert has as the rotational securing device a hexagon. which is the counterpart to the internal hexagon of the FRIALIT-2® implant. The ceramic sleeve is blaced on top of the titanium insert where it is rotationally secured by a slot and key connection. The titanium insert is color-coded in order to clearly differentlate the different diameters.
The diameters of the FRIALIT-2® CeraBase abutments correspond to the FRIALIT-2® implant diameters. The following diameters are available:
D3,8 mm, D4,5 mm, D5,5 mm and D6,5 mm.
The FRIALIT-2® CaraBase titanium insert is manufactured out of pure titanium grade II material which is in accordance to ASTM F 67 'Standard Specification for Unalloyed Titanium for Surgical Implant Application'.
The FRIALIT-209 CeraBase ceramic sleeve is manufactured out of medical grade aluminumdioxid ceramic which Is In accordance to ASTM F 603 'Standard Specification for High-Purity Dense Aluminum Oxide for Surgical Implant Application'.
X1.5. Intended Use
The FRIALIT-2® CeraBase abutment is intended for use of the following indications:
Fabrication of single crowns for the anterior maxilla and mandible where exceptional esthetics are required.
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: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
Premarket Notification 510(k) Artiole Name: FRIALIT-26 CeraBase Abusment
Image /page/1/Picture/3 description: The image shows a logo with a triangular shape at the top, resembling a roof or a mountain peak. Below the triangle, there is text that reads "FRIMATEC" in a stylized, slightly distressed font. The logo appears to be a simple, monochrome design, possibly representing a company or organization with a focus on construction, engineering, or a related field.
XI.G. Technological Characteristics
The technological characteristics of the FRIALIT-20 CeraBase abutment are substantially the same as the characteristics of the NobelBioCare CeraOne abutment. Both devices consist of two single parts. One part of each is an insert or abutment made of medical grade titanium. The second part of each device is a sleeve or cap composed of aluminumdioxide ceramic. Thus, the material of construction is identical for the FRIALIT-200 CeraBase and the NobelBioCere CereOne devices (i.e. titenium and aluminumdioxide). For ratation, both devices use a hexagon that complements the internal hexegon of the implant.
The tables below show technological properties and preclinical teating results for both the FRIALIT-26 CeraBase and the predicate device.
| Properties | FRIALIT-25 CeraBaseabutment | NobelBioCare CeraOneabutment |
|---|---|---|
| Al2O3 content | 99,6 weight-% | 99,0 weight-% |
| crystallogical phase | α-aluminumdioxide | α-aluminumdioxide |
| grain size parameters [µm] | d10 d50 d901,3 3,9 7,7 | d10 d50 d900,9 2,2 3,8 |
| FRIALIT-28 ceraBaseabutment | NobelBioCare CeraOneabutment | |
|---|---|---|
| static shear strength [lbs] | 99,2 | 74,5 |
| dynamic fatigue strength[lbs] | runout at 35 [lbs] | runout at 35 [lbs] |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes emanating from its head, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 1698 SED
FRIATEC AG C/O Darcy J. Madden, M.S., M.B.A., R.A.C. Regulatory Affairs Associate Authorized Regulatory Agent for FRIATEC AG Advanced Bioresearch Associates ABA SAN DIEGO One America Plaza 600 West Broadway, Suite 900 San Diego, California 92101-3302
Re : K980630 FRIALIT-2® CeraBase Trade Name: Requlatory Class: III Product Code: DZE Dated: June 5, 1998 Received: June 8, 1998
Dear Ms. Madden:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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), You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and ------adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions.
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Page 2 - Ms. Madden
comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.qov/cdrh/dsma/dsmamain.html".
Sincerely yours,
A. Butman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, -and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510(k) Number (if known)
Device Name:__FRIALIT-2(r) CeraBase
Indications For Use:
The FRIALIT-2(t) CetaBase abutment is intended The FRIALIT-2(t) Cerabase aon theme to rowns for "
for use in the fabrication of single crowns for for use in the fabrication of original and exceptional esthetics are required.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801:109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Pun
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number 1980630
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.