(44 days)
No
The description focuses on the chemical composition and physical properties of a resin glaze material, with no mention of AI or ML.
No
The device is a light-cure resin glaze material used for polishing dental restorations, not for treating diseases or conditions. Its function is to provide a smooth surface rather than to have a therapeutic effect on the body.
No
The device, SURFACE COAT, is a resin glaze material used for polishing dental restorations, not for diagnosing conditions. Its intended use is to provide a clear and smooth surface, not to identify or interpret medical conditions.
No
The device description clearly states it is a "single-component, light-cure resin glaze material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a glaze/polish for dental restorations and appliances. This is a direct application to materials used in the mouth, not for testing samples taken from the body.
- Device Description: The description details a light-cure resin glaze material applied to surfaces. This aligns with a dental restorative or finishing material, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on comparing the device's effectiveness and performance as a glaze/polish against predicate devices used for similar purposes. This is not related to diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely external to the body and related to the finishing of dental materials.
N/A
Intended Use / Indications for Use
SURFACE COAT is used to glaze/polish following restorations:
- Direct and indirect composite resins
- Acrylic provisional crowns and bridges
- Acrylic appliances
- Glass ionomers and resin-modified glass ionomers
Product codes
EBD
Device Description
SURFACE COAT is a single-component, light-cure resin glaze material that provides a clear and smooth surface, consisting of a multi-functional acrylate monomer that provides excellent durability and may reduce or even eliminate the need for manual polishing. SURFACE COAT has virtually no surface oxygen inhibition layer.
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
Since there is no applicable FDA's recognized standard or international standard concerning performance of this type of device, certain specifications are designed for SURFACE COAT, the applicant device, and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent to the predicate devices in terms of the effectiveness and performance.
Key Metrics
Not Found
Predicate Device(s)
K030354, K043168, K960464, K012737, K032455
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
DEC - 8 2006
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
ノ
October 24, 2006 Date:
।
510(k) Summary
- 510(k) owner (submitter)
ﺑ
୍ୟ
. .
| 1) Name | KURARAY MEDICAL INC. | |
|---|---|---|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan | |
| 3) Contact person | Michio Takigawa | |
| Quality Assurance Department | ||
| 4) Contact person in U.S. | Koji Nishida | |
| KURARAY AMERICA, INC. | ||
| 600 Lexington Avenue, 26th Floor | ||
| New York, NY 10022 | ||
| Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 | ||
| Fax: (212)-867-3543 | ||
| 2. Name of Device | ||
| 1) Trade / Proprietary name | SURFACE COAT | |
| 2) Classification name | Coating, Filling Material, Resin | |
| (21 CFR section 872.3310. Product code: EBD) | ||
| 3) Common name | Resin glaze material | |
| 3. Predicate device | ||
| 1) BISCOVER LIQUID POLISH | 510(k) Number: | |
| Product Code: | ||
| 21 CFR Section: | ||
| Applicant: | K030354 | |
| EBD | ||
| 872.3310 | ||
| BISCO, INC. | ||
| 2) BISCOVER LV | 510(k) Number: | |
| Product Code: | ||
| 21 CFR Section: | ||
| Applicant: | K043168 | |
| EBD | ||
| 872.3310 | ||
| BISCO, INC. | ||
| 3) C&B METABOND | 510(k) Number: | |
| Product Code: | ||
| 21 CFR Section: | ||
| Applicant: | K960464 | |
| EMA | ||
| 872.3275 | ||
| PARKELL, INC. |
| 4) CHROMA ZONE COLOR STAIN | 510(k) Number:
Product Code:
21 CFR Section:
Applicant: | K012737
EBF
872.3690
KURARAY MEDICAL, INC. |
|----------------------------|------------------------------------------------------------------|-----------------------------------------------------|
| 5) PANAVIA F 2.0 | 510(k) Number:
Product Code:
21 CFR Section:
Applicant: | K032455
EMA
872.3275
KURARAY MEDICAL, INC. |
3-1
KURARAY MEDICAL INC.
.
Quality Assurance Department
1
-
- Description of device
SURFACE COAT is a single-component, light-cure resin glaze material that provides a clear and smooth surface, consisting of a multi-functional acrylate monomer that provides excellent durability and may reduce or even eliminate the need for manual polishing. SURFACE COAT has virtually no surface oxygen inhibition layer.
- Description of device
- Intended use
SURFACE COAT, the applicant device, is used to glaze/polish following restorations:
- Direct and indirect composite resins
- Acrylic provisional crowns and bridges
- Acrylic appliances
- Glass ionomers and resin-modified glass ionomers
SURFACE COAT shares the same intended use as those included in the intended uses of BISCOVER LIQUID POLISH and BISCOVER LV, the predicate devices. SURFACE COAT is indicated for more limited uses than the predicate devices, as it is not used for enamel.
-
- Substantial equivalence
The safety and effectiveness of SURFACE COAT, the applicant device, are equivalent to the predicate devices.
- Substantial equivalence
-
- Effectiveness / Performance
Since there is no applicable FDA's recognized standard or international standard concerning performance of this type of device, certain specifications are designed for SURFACE COAT, the applicant device, and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent to the predicate devices in terms of the effectiveness and performance.
- Effectiveness / Performance
-
- Safety
SURFACE COAT, the applicant device, contains chemical ingredients which have been used in the predicate devices and copes with any possible risk in a similar manner as the predicate devices suggesting the safety of the applicant device is substantially equivalent to the predicate devices.
- Safety
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 8 2006
Kuraray Medical, Incorporated C/O Mr. Koji Nishida Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022
Re: K063228
Trade/Device Name: Surface Coat Regulation Number: 21 CFR 872.3310 Regulation Name: Coating Material for Resin Fillings Regulatory Class: II Product Code: EBD Dated: October 24, 2006 Received: October 31, 2006
Dear Mr. Nishida:
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 controls provisions of the Act. The general controls provisions of the Act include requirements 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 your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
.
3
Page 2 - Mr. Koji Nishida
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Smitte y. Michael Davis.
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
4
Indications for Use
06 3228 510(k) Number (if known):
Device Name: __SURFACE COAT
Indications for Use:
SURFACE COAT is used to glaze/polish following restorations:
- Direct and indirect composite resins
- Acrylic provisional crowns and bridges
- Acrylic appliances
- Glass ionomers and resin-modified glass ionomers
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ N/A (21 CFR 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 Dunne
ි වෙන්වන A. Dona
KD630235