Adhesion of metal posts, metal inlays, onlays, crown and bridges
Repair of fractures resin-based facing crowns and porcelain-fused metal crowns
Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures

Device Description

ALLOY PRIMER is an adhesion primer between dental metal alloy and resin-based material for dental practitioner or dental technician, and comprises methacrylate monomers and solvent. It is used a kind of bonding agent between metal and/or tooth substrate using resin-based materials for the intended uses.

AI/ML Overview

The provided document is a 510(k) summary for the device ALLOY PRIMER by Kuraray Medical Inc. It primarily focuses on changing the manufacturer's name and address and states that the device is "essentially the same" as a previously cleared predicate device (K974089).

Therefore, the document does not contain information about new acceptance criteria or a study proving the device meets new acceptance criteria. It refers to the predicate device having already satisfied these requirements.

Based on the provided text, I cannot fill in the requested table and study details because the submission is for an administrative change and not for a new device requiring a new performance study.

However, I can extract information related to what typically would be expected if such a study were present:

Missing Information:

Acceptance Criteria and Reported Device Performance: This document does not establish new acceptance criteria or report new device performance data. It relies on the predicate device's performance.
Sample size used for the test set and the data provenance: Not applicable, as no new test set was used for a new study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable.
Type of ground truth used: Not applicable.
Sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What the document does state:

Device Name: ALLOY PRIMER
Predicate Device: ALLOY PRIMER by Kuraray Co., Ltd. (K974089)
Reason for 510(k) submission: "to alter the name and address of manufacturer, and not to intend other changes."
Technological Characteristics and Safety: "This device is essentially the same as ALLOY PRIMER manufactured by Kuraray Co., Ltd. Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as ALLOY PRIMER (K974089)."
Intended Use: "The intended uses of this device are... completely the same as ALLOY PRIMER manufactured by Kuraray Co., Ltd. (K974089)."
1. Adhesion of metal posts, metal inlays, onlays, crown and bridges
2. Repair of fractures resin-based facing crowns and porcelain-fused metal crowns
3. Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures.
Classification Name: Resin tooth bonding agent (21CFR 872.3200)
Regulatory Class: II
Product Code: KLE

Conclusion:

This 510(k) submission is for a change in manufacturer information, asserting substantial equivalence to a previously cleared device. It does not present new acceptance criteria or a study demonstrating the device meets such criteria because it claims the device is identical in all relevant aspects to its predicate. Therefore, the detailed information about studies and acceptance criteria is inherent to the predicate device's clearance (K974089) and not present in this document.

Summary

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INC. I Material Department , 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN 81-6-348-2603

K012436

SEP - 4 2001

510(k) SUMMARY

1. Submitter

1) Name	KURARAY MEDICAL INC.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-8622, Japan
3) Contact person	Koji NishidaDENTAL MATERIAL DEPARTMENT
4) Date	July 23, 2001
5) Contact person in U.S.A.	Masaya Sasaki30th Fl. Metlife Building, 200 Park Avenue, New YorkNY 10166Telephone : (212)-986-22301(800)-879-1676Facsimile : (212)-867-3543

2. Name of Device

1) Proprietary Name	ALLOY PRIMER
2) Classification Name	Resin tooth bonding agent (21CFR 872.3200)
3) Common/Usual Name	Metal adhesive primer

3. Predicate device:

Kuraray Co., Ltd. will transfer the medical device business and the relevant functions including manufacturing facilities to its subsidiary company named Kuraray Medical Inc. on October 1st 2001. The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes.

The predicate device is as follow.

ALLOY PRIMER by Kuraray Co., Ltd. (K974089)

4. Description for the premarket notification

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5. Statement of the intended use

The intended uses of this device are as follows. They are completely the same as ALLOY PRIMER manufactured by Kuraray Co., Ltd. (K974089).

1. Adhesion of metal posts, metal inlays, onlays, crown and bridges.
1. Repair of fractures resin-based facing crowns and porcelain-fused metal crowns
1. Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures

6. Statement of the technological characteristics and safety

This device is essentially the same as ALLOY PRIMER manufactured by Kuraray Co., Ltd. Therefore the technological characteristics, chemical ingredients and safety of this (K974089). device are completely the same as ALLOY PRIMER.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 4 2001

Kuraray Medical, Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30th Floor Metlife Building 200 Park Avenue 10166 New York, New York

K012436 Re : Modification To Alloy Primer Trade/Device Name: 872.3200 Requlation Number: Regulatory Class: II Product Code: KLE Dated: July 23, 2001 Received: July 31, 2001

Dear Ms. Sasaki:

We have reviewed your Section 510(k) notification of intent to we have levice your boosed above and we have determined the market the device force enouvalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the cholobase, commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the chactment acco on reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the reachar robe, subject to the general The general controls controls provisions of the Act. provisions of the Act include requirements for annual provisions of the not includes, 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 (operai ochorsuch additional controls. Existing major be subject to back acabour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਉ rederal &chartially eroses mination assumes compliance with Bubbeancially oqualizaturing Practice requirements, as set Enc Current Souality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to Aomilitocracion (CMP regulation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2- Ms. Sasaki

concerning your device in the Federal Register. Please note: concerning your device in ence innotification submission does this response to your premarker needbase under sections 531
not affect any obligation you might have under the Electronic not allect any obligation you mages under the Electronic through 542 of the Act for acvices ander of other Federal laws or regulations.

This letter will allow you to begin marketing your device as Inis recei will arrow your of the motification. The FDA described in your 510 kr premaince of your device to a legally finding of substancial equivalence of polassification for your marketed predicate device rebares in opened to the market.

If you desire specific advice for your device on our labeling II you desire specific advice is do and additionally 809.10 for in regulation (21 crk Fare Son and Son and the Office of Compliance at (301) 594-4613. Additionally, for questions on Compliance at (501) 331 issing of your device, please contact the promocion and advercibing on Journal (301) Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premarket notification - (2rch Joies under the Act may be Informacion on your rision of Small Manufacturers, obtained from the Division of Email - Bilained at its tollefreeddress International and Consumer-ABB-ABB-Aits Internet address (800) 636-2041 Szvirgdrh/dsma/dsmamain.html.

Sincerely yours,

Timothy A. Ulatowski

Tim 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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[ALLOY PRIMER, Kuraray Medical Inc.]

Image /page/4/Picture/1 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '0', '1', '2', '4', '3', and '6'. The digits are written in a clear, legible style, with consistent spacing between them. The image appears to be a close-up of the handwritten sequence.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ALLOY PRIMER

Indications for Use

Statement of the intended use

ALLOY PRIMER is indicated for the following applications:

Adhesion of metal posts, metal inlays, onlays, crown and bridges
Repair of fractures resin-based facing crowns and porcelain-fused metal crowns
Fabrication of removable dentures with metal base, clasp or attachment. Repair of dentures

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Part 21 CFR 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.