HI DENSE TC

• K Number: K971927
• Device Name: HI DENSE TC
• Manufacturer: SHOFU DENTAL CORP.
• Date Cleared: 1997-06-30 ( 34 days)
• Product Code: EMA
• Regulation Number: 872.3275

Intended Use

HI DENSE TC is a glass ionomer sliver reinforced restorative dental product. It is indicated for use in: 1. Class I and II cavities in deciduous teeth. 2. Repair of amalgam restored teeth when either tooth or restoration has fractured. 3. Class I and II cavities in selected permanent teeth. 4. Lining under amalgam and posterior composite restorations. 5. In other classes of cavity where radiopacity rather than aesthetics is a prime requirement. 6. As a core build-up material under crowns. 7. On the root surfaces for locating overdentures. 8. Long term temporary replacements for cusp(s). 9. Repair to crown margins.

Device Description

HI DENSE TC is a glass ionomer sliver reinforced restorative dental product.

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a dental restorative material and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.

Therapeutic

No
The device is a restorative dental product used for filling cavities and other dental repairs, which are structural restorations rather than therapeutic treatments.

Diagnostic

No.
The document describes the device as a restorative dental product used for filling cavities and repairing teeth, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "glass ionomer sliver reinforced restorative dental product," which is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly describes a dental restorative material used in the mouth to fill cavities, repair teeth, and build up cores. This is a direct treatment applied to the patient's body.
• Device Description: The description confirms it's a "restorative dental product."
• Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (in vitro), such as blood, urine, or tissue. The device is not used for diagnosis or screening based on laboratory tests.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

HI DENSE TC is a glass ionomer sliver reinforced restorative dental product. It is indicated for use in:

• 1. Class I and II cavities in deciduous teeth.
• 2. Repair of amalgam restored teeth when either tooth or restoration has fractured.
• 3. Class I and II cavities in selected permanent teeth.
• 4. Lining under amalgam and posterior composite restorations.
• 5. In other classes of cavity where radiopacity rather than aesthetics is a prime requirement.
• 6. As a core build-up material under crowns.
• 7. On the root surfaces for locating overdentures.
• 8. Long term temporary replacements for cusp(s).
• 9. Repair to crown margins.

Product codes

EMA

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

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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)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is a stylized image of a human figure, represented by three overlapping profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Hideaki Kumazawa Vice President and Official Correspondent Shofu Dental Corporated , 4025 Bohannon Drive 94025 Menlo Park, California

JUN 30 1997

Re : K971927 Hi Dense TC Trade Name: Requlatory Class: II Product Code: EMA Dated: May 22, 1997 May 27, 1997 Received:

Dear Mr. Kumazawa:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

1

Page 2 - Mr. Kumazawa

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

thy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

K971927 510(k) Number:

HI DENSE TC Device Name:

Indications For Use:

HI DENSE TC is a glass ionomer sliver reinforced restorative dental product. It is indicated for use in:

• 1. Class I and II cavities in deciduous teeth.
• 2. Repair of amalgam restored teeth when either tooth or restoration has fractured.
• 3. Class I and II cavities in selected permanent teeth.
• 4. Lining under amalgam and posterior composite restorations.
• 5. In other classes of cavity where radiopacity rather than aesthetics is a prime requirement.
• 6. As a core build-up material under crowns.
• 7. On the root surfaces for locating overdentures.
• 8. Long term temporary replacements for cusp(s).
• 9. Repair to crown margins.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number	K97927

Prescription Use	✓	OR	Over-The-Counter Use ______
(Per 21CFR§801.109)

(Optional Format 1-2-96)