(161 days)
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No
The summary describes preformed plastic denture teeth and does not mention any software, algorithms, or AI/ML capabilities.
No
The device, Curative Dental Acrylic Teeth, is described as preformed plastic denture teeth used as teeth in dentures. It is a prosthetic device for replacement, not a device used for treating or curing a disease or condition.
No
The device is described as preformed plastic denture teeth, intended for use as teeth in dentures. Its intended use is to replace teeth, not to diagnose a condition.
No
The device description clearly states it is "preformed plastic denture teeth," which are physical objects, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as teeth in dentures." This is a prosthetic device used in the body, not a test performed on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description confirms they are "preformed plastic denture teeth." This aligns with a prosthetic device.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic or monitoring information about a patient's health
IVDs are used to perform tests outside the body (in vitro) on samples to gain information about a patient's health status. Curative Dental Acrylic Teeth are physical components used inside the mouth as part of a denture.
N/A
Intended Use / Indications for Use
Curative Dental Acrylic Teeth are preformed plastic denture teeth intended for use as teeth in dentures.
Product codes (comma separated list FDA assigned to the subject device)
ELM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Data were provided to demonstrate that the Curative Dental Acrylic Teeth comply with applicable safety and performance standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 872.3590 Preformed plastic denture tooth.
(a)
Identification. A preformed plastic denture tooth is a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
0
AUG 2 5 2006
510(k) Premarket Notification for the Curative Dental Acrylic Teeth
COMPANY NAME AND ADDRESS 1.
Sponsor 1.1
Curative, LLC 2275 East Bayshore Road, Suite 105 Palo Alto, CA 94303 Telephone: 650-856-9600 Facsimile: 650-856-9601
1.2 Manufacturer
Shanghai Dental Materials Factory Shanghai Medical Instruments Co., Ltd No. 690 Tian Tong An Road Shanghai, China, 200081 Telephone: 86-21-56664470 Facsimile: 86-21-65402339
1.3 Consultant/Contact
Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
| Primary Contact: | James R. Veale |
|---|---|
| Telephone: | 719-495-3438 |
| Facsimile: | 719-495-3438 |
2. DEVICE NAME
| Proprietary Name: | Curative Dental Acrylic Teeth |
|---|---|
| Common/Usual Name: | Acrylic Denture Teeth |
| Classification Name: | Preformed plastic denture tooth (21CFR 872.3590) |
1
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The Curative Dental Acrylic Teeth are intended for the same purpose as the predicate products, and are made of the same or similar materials.
PERFORMANCE TESTING 7.
Data were provided to demonstrate that the Curative Dental Acrylic Teeth comply with applicable safety and performance standards.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that resemble a person's head and torso. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2006
Curative, LLC C/O Mr. James R. Veale Senior Technical Adviser Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K060720
Trade/Device Name: Curative Dental Acrylic Teeth Regulation Number: 872.3590 Regulation Name: Preformed Plastic Denture Tooth Regulatory Class: II Product Code: ELM Dated: July 27, 2006 Received: July 28, 2006
Dcar Mr. Veale:
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. Veale
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" (21CFR Part 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clive
Chin-Lin, Ph.D.
Chiu Lin, Ph.D Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number:
1060720
Device Name: Curative Dental Acrylic Teeth
Indications For Use:
Curative Dental Acrylic Teeth are preformed plastic denture teeth intended for use as teeth in dentures.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER
CONTINUE OF AND THE WEST VESTIGATIO PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kei. Muly for MHR
Sign-Off)
thesiology, General Hospital,
librish of Anesthesiolo I ් 1 ු(k) Number: