BIO 60 by KODENT, INC. | FDA 510(k) Summary

This K041378 submission for the BIO 60 device, a gold cylinder for UCLA Abutment, relies on a comparison to a legally marketed predicate device, the Southern Implants Cylinder, using established industry standards rather than a clinical study with acceptance criteria in the traditional sense. Therefore, many of the requested fields are not applicable (N/A) as this is a material comparison and not an AI/software device.

Here's an analysis of the provided information based on the requested categories:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Predicate Performance)	Reported Device Performance (BIO 60)
Composition (weight)
Au (%): 60.00	Au (%): 60.00
Pt (%): 19.00	Pt (%): 15.20
Pd (%): 20.00	Pd (%): 24.00
In (%): 1.0	In (%): 0.8
Physical and Mechanical Properties
Melting Point Range (°F): 1,475	Melting Point Range (°F): 1,400-1,490
Hardness (vickers): 265	Hardness (vickers): 250
Proof Strength (0.2%): 635 N/mm-2	Proof Strength (0.2%): 645 N/mm-2
CTE (x10-6/°C): 12.0	CTE (x10-6/°C): 11.8
Density (g/c x103m3): 18.5	Density (g/c x103m3): 17.9

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This submission is for a material comparison based on established test methods (ANSI/ADA 5 and ISO 9693) for dental alloys, not a clinical study on a "test set" in the context of image analysis or AI. The performance data presented are for the material itself.
Data Provenance: The data provenance is derived from laboratory testing of the material's properties according to the specified standards. The country of origin of the data is not explicitly stated but would presumably be from the manufacturer's testing facilities or a contracted lab. This is retrospective data, as it reflects the properties of the manufactured material.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in this context would refer to the accurate measurement of material properties, which are established through standardized laboratory tests, not by expert consensus or interpretation of images. The 'truth' is the measured physical and chemical properties.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically employed in studies where expert interpretation or consensus is required (e.g., medical imaging reads). This submission relies on objective, repeatable laboratory measurements of material properties.

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 submission is for a dental material (gold cylinder), not an AI or software device. Therefore, no MRMC study, human readers, or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This submission is for a dental material, not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the material comparison is the measured physical and chemical properties of the alloy, determined according to recognized industry standards (ANSI/ADA 5 and ISO 9693). This is objective, quantitative data from laboratory testing.

8. The sample size for the training set

Not applicable. This submission is for a material comparison, not an AI or machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI device, this question is not relevant.

Summary

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AUG - 2 2004

K041378

510(K) SUMMARY

Submitter of 510(k):	KoDent, Inc.9778 Katella Ave. Ste.215, Anaheim, CA 92804Phone: 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 PointRange (°F)	Hardness(vickers)	ProofStrength(0.2%)	CTE(x10-6/°C)	Density(g/cx103m3)
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

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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.

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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

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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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Regulation Number and Section

§ 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.