(69 days)
No
The 510(k) summary describes a standard dental implant system made of titanium, focusing on mechanical properties, dimensions, and sterilization. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a dental implant system intended to restore a patient's chewing function, which is a therapeutic purpose.
No
The device description and intended use clearly state that the SICace System Dental Implant is an implantable device used to restore chewing function, not to diagnose a condition or disease.
No
The device description clearly details physical components made of titanium (implants and abutments) and mentions sterilization processes, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be implanted in the jaw to restore chewing function by supporting prosthetic attachments. This is a surgical and mechanical function within the body.
- Device Description: The device is a physical implant made of titanium, designed for surgical placement and mechanical connection with abutments and prosthetics.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are typically used to test samples like blood, urine, or tissue to detect diseases, conditions, or measure substances. This dental implant system does not perform any such diagnostic function.
N/A
Intended Use / Indications for Use
The SICace System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SICace System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function.
Patient's must be applicable for dental treatment with endosseous implants.
In cases where the ridge is too narrow to receive a 4.0 mm or a 5.0 mm diameter implant, the 3.4 mm implant can be used. Because of reduced strength due to the small diameter, these implants should be rigidly joined to other implants and used only where loads are not extreme.
The SICace System Abutment is intended to be placed into the SICace System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.
Product codes
DZE, NHA
Device Description
SICace dental implant system is a root-form endosseous dental implant device made out of grade 4 titanium according ASTM F 67. The implants are available in three different diameters (ø3.4 mm, ø4.0 mm, ø5.0 mm) and various lengths from 9.5 mm. The anchorage surface is grit blasted and acid etched for faster osseointegration and secondary stability.
Equal to the predicate device SICpro dental implant, the face side of the SICace dental implant has a hexagon drill hole and a standard screw thread to ensure and anti-rotational connection of the congruent abutment and the implant. Throughout the different diameters the hexagon drill hole has identical measurements.
SICace dental implants are delivered single packed in combination with an implant cover screw and supplied in sterile condition (sterilized by gamma-radiation).
SIC angled abutments are various in lengths and diameters and made out of titanium ASTM F 136. Through a hexagon socket and a vertical drill hole, the abutments can be connected with the implant secure and anti-rotational.
SIC angled abutments are supplied in non sterile condition. These parts of the system can be sterilized by the user by using a standardized and validated sterilization process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and/or lower jaw arches
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)
Not Found
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
Image /page/0/Picture/1 description: The image shows a logo with the letters "SIC" inside of a circle. There is a registered trademark symbol to the upper right of the circle. The letters are in a sans-serif font and are black. The circle is also black and appears to be a single line.
AUG - 8 2006
K061500
SICace Dental Implant System
and
SIC Angled Abutments
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
DATE: 2006-05-26
Establishment:
SIC invent AG Birmannsgasse 3 Basel, SWITZERLAND 4055 Registration Number: 3004443656
Official Correspondent:
Franz Menean SIC invent AG Birmannsgasse 3 Basel, SWITZERLAND 4055 Phone: +41-61-2613966 Fax: +41-61-2613968 Email: franz.menean@sic-invent.com
Owner/Operator:
SIC invent AG Birmannsgasse 3 Basel, SWITZERLAND 4055 Owner/Operator Number: 9060857
US Agent:
MEDAGENT, Inc. Christa Heitmann-Franke One Park Ave, Suite #5G Hampton, 03842 NH Phone: 603-758-1029 Fax: 603-758-1029 Email: mail@medagent-usa.com
1
Description of the Device 1.
1.1. Device Name & Classification
| SiCace Dental Implant | SIC angled Abutment | |
|---|---|---|
| Proprietary Device Name: | ENDOSSEOUS IMPLANT, OSSEOINTEGRATED TITANIUM | |
| IMPLANT | ||
| Common/Generic Device Name: | ENDOSSEOUS DENTAL IMPLANT, COMPONENTS & AC- | |
| CESSORIES | ||
| Classification Name: | IMPLANT, ENDOSSEOUS, ROOT-FORM | |
| Trade Name: | SICace Dental Implant | SIC Angled Abutments |
| Device Class: | 2 | |
| Product Code: | DZE | |
| Regulation Number: | 872.3640 | |
| Medical Specialty: | Dental |
1.2. Description of SICace Dental Implant
SICace dental implant system is a root-form endosseous dental implant device made out of grade 4 titanium according ASTM F 67. The implants are available in three different diameters (ø3.4 mm, ø4.0 mm, ø5.0 mm) and various lengths from 9.5 mm. The anchorage surface is grit blasted and acid etched for faster osseointegration and secondary stability.
Equal to the predicate device SICpro dental implant, the face side of the SICace dental implant has a hexagon drill hole and a standard screw thread to ensure and anti-rotational connection of the congruent abutment and the implant. Throughout the different diameters the hexagon drill hole has identical measurements.
SICace dental implants are delivered single packed in combination with an implant cover screw and supplied in sterile condition (sterilized by gamma-radiation).
1.3. Description of SIC Angled Abutment
SIC angled abutments are various in lengths and diameters and made out of titanium ASTM F 136. Through a hexagon socket and a vertical drill hole, the abutments can be connected with the implant secure and anti-rotational.
SIC angled abutments are supplied in non sterile condition. These parts of the system can be sterilized by the user by using a standardized and validated sterilization process.
2. Predicate Devices
- . SIC invent AG, SICpro Dental Implant System, K040757;
- 미 Institut Straumann AG, ITI® synOcta Angled Abutments, K013891
- FRIADENT GmbH, XiVE@ TG Abutment Accessory to the XiVE@ TG Dental Implant Sys-. tems, K032302.
2
Image /page/2/Picture/1 description: The image shows a logo with the letters "SIC" inside of a circle. There is a registered trademark symbol in the upper right quadrant of the circle. The letters are in a sans-serif font and are black. The circle is also black and appears to be a thick line.
Indication for Use 3.
The SICace System Dental Implant is a root form endosseous dental implant system that is indicated to be implanted in the upper and/or lower jaw arches. The implants may be used in combination with various SICace System Abutments for single or multiple unit prosthetic attachment to restore a patient's chewing function.
Patient's must be applicable for dental treatment with endosseous implants.
In cases where the ridge is too narrow to receive a 4.0 mm or a 5.0 mm diameter implant, the 3.4 mm implant can be used. Because of reduced strength due to the small diameter, these implants should be rigidly joined to other implants and used only where loads are not extreme.
The SICace System Abutment is intended to be placed into the SICace System Implant to provide a safe and effective fit of screw retained and/or cementable crowns and bridges.
Conclusions 4.
Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the SICace Dental Implant System, Abutments and Accessories are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services, USA. The logo consists of two main elements: the department's name encircling the image and a symbol. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The symbol is a stylized representation of three human figures connected at the base, with their arms raised and intertwined.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 2006
Mr. Franz Menean Managing Director/Senior Consultant SIC Invent AG Birmannsgasse 3 Basel. SWITZERLAND 4055
Re: K061500
Trade/Device Name: SIC®ace Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 28, 2006 Received: June 1, 2006
Dear Mr. Menean:
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 approvisions of the Act. The general controls provisions of the Act include econorements for annual registration, 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 will), it intry be basyon in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
4
Page 2 -- Mr. Menean
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), n 90 a dontact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Smite y. Michie MD.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K061500
Device Name: SIC®ace Dental Implant System
Indications for Use:
The SICace System Dental Implant is a root form endosseous dental implant system that is indi-The SICace System Dental Implant is a root form Chaoses. The implants may be used in combicated to be implanted in the upper andror low fan arones. And prosthetic attachment to restore a patient's chewing function.
Patient's must be applicable for dental treatment with endosseous implants.
Pattern s must de applicable for dentify a 4.0 mm or a 5.0 mm diameter implant, the 3.4
In cases where the ridge is too narrow to receive a 4.0 mm or all diameter, these impl In cases where the nuge is too hanow to receive a 1.6 mill diameter, these implants
mm implant can be used. Because of reduced strength due to the small diament on the mo mm implant can be used. Decadise of roduced only where loads are not extreme.
Should be nglury Johnst to other informed to be placed into the SICace System Implant to provide The SICace System Abdument is intendoute to be provins and bridges.
Prescription Use YES_ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __NO_X (21 SFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Punno
Jon Sign-Off) ം of Anesthesiology, General Hospital, cuon Control, Dental Devices
") Number:
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