(70 days)
Not Found
Not Found
No
The device description and performance studies focus on the material composition and physical properties of a gold cylinder for dental implants, with no mention of AI or ML.
No.
The device is a component used in the fabrication of dental implant superstructures, not a device that directly provides therapy or treatment.
No
The device description and intended use state that "BIO 60 is intended for use in the fabrication of implant superstructures and gold cylinders for dental implants." This indicates it is a component used in the construction of dental devices, not for diagnosing medical conditions.
No
The device description explicitly states it is a "Gold cylinder for using UCLA Abutment," indicating a physical hardware component made of gold. The performance studies also focus on the composition and physical/mechanical properties of this material.
Based on the provided information, the BIO 60 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in the fabrication of implant superstructures and gold cylinders for dental implants." This describes a material used in the manufacturing of a medical device (dental implants), not a test performed on a biological sample to diagnose a condition.
- Device Description: It's described as a "Gold cylinder for using UCLA Abutment," which is a component of a dental implant system.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or prediction of disease
- Use in a laboratory setting
The information provided focuses on the material composition and physical/mechanical properties of the gold alloy, which are relevant to its use as a structural component in dental implants.
Therefore, the BIO 60 is a material used in the fabrication of a medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
BIO 60 is intended for use in the fabrication of implant superstructures and gold cylinders for dental implants.
Product codes (comma separated list FDA assigned to the subject device)
EJT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.
0
AUG - 2 2004
510(K) SUMMARY
| Submitter of 510(k): | KoDent, Inc.
9778 Katella Ave. Ste.215, Anaheim, CA 92804
Phone: 714- 537-0600, Fax: 714- 537-0601 | | | |
|----------------------|----------------------------------------------------------------------------------------------------------|--|--|--|
| Contact person: | Dae Kyu Chang | | | |
| Phone: | (714) 537-0600 | | | |
| Fax: | (714) 537-0601 | | | |
| E-mail: | KoDentinc@yahoo.com | | | |
| Date of Summary: | May 21, 2004 | | | |
| Trade name: | BIO 60 | | | |
| Common: | Gold cylinder for using UCLA Abutment | | | |
| Classification name: | Gold based alloys and precious metal alloys for clinical use | | | |
| Product code: | EJT | | | |
| Classification: | Class II | | | |
Legally marketed device: Southern Implants Cylinder 510(k) number:
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
Composition (weight)
| Au (%) | Pt (%) | Pd (%) | In (%) | |
|---|---|---|---|---|
| Ceramicor | 60.00 | 19.00 | 20.00 | 1.0 |
| BIO 60 | 60.00 | 15.20 | 24.00 | 0.8 |
Comparison of physical and mechanical properties:
| Alloy | Melting Point
Range (°F) | Hardness
(vickers) | Proof
Strength
(0.2%) | CTE
(x10-6/°C) | Density
(g/c
x103m3) |
|-----------|-----------------------------|-----------------------|-----------------------------|-------------------|----------------------------|
| Ceramicor | 1,475 | 265 | 635N/mm-2 | 12.0 | 18.5 |
| BIO 60 | 1,400-1,490 | 250 | 645N/mm-2 | 11.8 | 17.9 |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling a bird or abstract human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 2 2004
Mr. Dae Kyu Chang Owner Kodent, Incorporated 9778 Katella Avenue, Suite 215 Anaheim, California 92804
Re: K041378
Trade/Device Name: BIO 60 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: May 21, 2004 Received: May 24, 2004
Dear Mr. Chang:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection broky proximally equivalent (for the indications for relerenced above and nave decemined aread predicate devices marketed in interstate commerce use stated in the encreatify management date of the Medical Device Amendments, or to devices that prior to May 26, 1776, the chaemism and the Reseral Food, Drug, and Cosmetic liave been tectassified in acceration of a premarket approval application (PMA). You may, Act (Act) that ao not require apple for the general controls provisions of the Act. The general therefore, market the device, subject to the generation, listing of devices, good Controls provisions of missions and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into existing major regulations affecting your device can be may be subject to such additional controller and to 898. In addition, FDA may publish found in the Sourcerning your device in the Federal Register.
2
Page 2 -- Mr. Dae Kyu Chang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's issualled of a sacesting complies with other requirement of the Act of that FDA nas made a ucternmation mar your aed by other Federal agencies. You must comply with any Federal statures and regulations administration of to: registration and listing (21 CFR Part 877); all the Act s requirements, menuding, but nov incenter requirements as set forth in the quality labeling (21 CFR Part 001), good management of and if applicable, the electronic product radiation systems (QS) rogards (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) I ms letter will anow you to oogin mantening of substantial equivalence of your device to a legally prematket notification: "The PDF Intentig sification 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), please If you desire specific advice for your a011. Additionally, for questions on the promotion comact the Office of Compliance at (301) 594-4639 Compliance at (301) 594-4639. Also, 1 and advertising of your device, prease corranding by reference to premarket notification" (21CFR please note the regulation entition, "Fasseral information on your responsibilities under the Act may F all 807.77) you they obtain. Other gol Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours,
Chiu S. Lin, PhD
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K041378
Device Name: BIO 60 Indications for Use:
BIO 60 is intended for use in the fabrication of implant superstructures and gold cylinders for dental implants.
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 ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Angela Blackwell for ASR
Division of Anesthesiology, Genera Infection Control, Dental Devices
510(k) Number: K041378
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