(198 days)
No
The device description and performance studies focus on the material properties and mechanical strength of the abutment, with no mention of AI or ML technologies.
No
The device is an abutment for dental implants, used for fabricating crowns, not for treating diseases or conditions.
No
Explanation: The device is an abutment for dental implants, used for fabrication of single crowns. Its description and intended use clearly indicate it is a prosthetic component, not a tool for diagnosis.
No
The device description clearly states it is a two-part abutment consisting of a titanium insert and a ceramic sleeve, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The FRIALIT-2® CeraBase abutment is a dental implant component used for fabricating single crowns in the anterior maxilla and mandible. It is a physical device implanted into the body, not a tool for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens, chemical reactions, or diagnostic purposes related to disease or health conditions.
Therefore, the FRIALIT-2® CeraBase abutment is a medical device, specifically a dental implant component, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
The FRIALIT-2(r) CetaBase abutment is intended for use in the fabrication of single crowns for original and exceptional esthetics are required.
Product codes
DZE
Device Description
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'.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior maxilla and mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The tables below show technological properties and preclinical teating results for both the FRIALIT-26 CeraBase and the predicate device.
| Properties | FRIALIT-25 CeraBase
abutment | NobelBioCare CeraOne
abutment |
|---|---|---|
| Al2O3 content | 99,6 weight-% | 99,0 weight-% |
| crystallogical phase | α-aluminumdioxide | α-aluminumdioxide |
| grain size parameters [µm] | d10 d50 d90
1,3 3,9 7,7 | d10 d50 d90
0,9 2,2 3,8 |
| | FRIALIT-28 ceraBase
abutment | NobelBioCare CeraOne
abutment |
|---|---|---|
| static shear strength [lbs] | 99,2 | 74,5 |
| dynamic fatigue strength
[lbs] | runout at 35 [lbs] | runout at 35 [lbs] |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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ಸ್ಟ್ರೀಯ
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
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 CeraBase
abutment | NobelBioCare CeraOne
abutment |
|----------------------------|---------------------------------|----------------------------------|
| Al2O3 content | 99,6 weight-% | 99,0 weight-% |
| crystallogical phase | α-aluminumdioxide | α-aluminumdioxide |
| grain size parameters [µm] | d10 d50 d90
1,3 3,9 7,7 | d10 d50 d90
0,9 2,2 3,8 |
| | FRIALIT-28 ceraBase
abutment | NobelBioCare CeraOne
abutment |
|-----------------------------------|---------------------------------|----------------------------------|
| static shear strength [lbs] | 99,2 | 74,5 |
| dynamic fatigue strength
[lbs] | runout at 35 [lbs] | runout at 35 [lbs] |
2
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.
3
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
4
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