(61 days)
Not Found
No
The 510(k) summary describes a dental restorative material and does not mention any AI or ML components.
No
The device is a restorative material used to repair defects in teeth, rather than to treat or cure a disease or condition.
No
Explanation: The device is a dental restorative material used to restore carious lesions or structural defects, not to diagnose them.
No
The device description clearly states it is a "dental restorative 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 is to "restore carious lesions or structural defects in teeth." This is a direct treatment or restoration of a physical structure within the body (teeth).
- Device Description: The description reinforces the intended use as a "dental restorative material."
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are used in vitro (outside the body) to analyze these specimens.
This device is clearly a medical device used for direct treatment/restoration within the oral cavity, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration.
Product codes
EBF
Device Description
Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
APR 2 2 2002
510(K) SUMMARY 21.0
Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration. Sonata Micro Hybrid Composite is substantially equivalent to Conquest Crystal, K932154 and other dental restorative resin composites on the market.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
APR 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Annmarie Tenero Jeneric/Pentron, Incorporated 53 North Plains Industrial Road Wallingford, Connecticut 06492
Re: K020555
Trade/Device Name: Sonata Micro Hybrid Composite Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 19, 2002 Received: February 20, 2002
Dear Ms. Tenero:
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 vour 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.
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.
2
Page 2 -- Ms. Annmarie Tenero
You must comply with all the Act's requirements, including, but not limited to: registration I ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 OF RT rat 807), assimm (QS) regulation (21 CFR Part 820); and if requirements as set form in are quality ijon 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 11113 letter will and w yours of substantial equivalence of your device 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 IT you desire specific act res 10.1 for in vitro diagnostic devices), please contact the and additionally 21 CF1 (301) 594-4613. Additionally, for questions on the promotion and Office of Colliphance wice, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and alle Act may be vealined 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 yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
5.0 INDICATION FOR USE STATEMENT
5100) NUMBER (IF KNOWN):
DEVICE NAME: Sonata Micro Hybrid Composite
INDICATION FOR USE:
Sonata Micro Hybrid Composite is a dental restorative material intended for use to restore carious lesions or structural defects in teeth in combination of conditioners such as bonding, luting, etching agents commonly used in tooth restoration.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED.)
Image /page/3/Figure/6 description: The image shows a form titled "Concurrence of CDRH, Office of Device Evaluation (ODE)". The form has two options: "Prescription Use (Per 21 CFR 801.109)" and "Over-The-Counter-Use (Optional Format 1-2-96)". The prescription use option has a checkmark next to it. The number 5.0 is written on the right side of the form, and the signature of "Susan Runo" is at the bottom, along with the text "(Division Sign-Off) Division of Dental, Infection Control".
and General Hospital Devices Jeneric/Pentron, Inc. 510K Submission - Sonata Micro Hybrid Composite 10(k) Number _________________________________________________________________________________________________________________