(58 days)
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Not Found
No
The provided 510(k) summary does not contain any mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses solely on the intended use and indications for a dental restorative material.
Yes
The device is described for various dental restorations and fillings, which are therapeutic interventions.
No
The "Intended Use / Indications for Use" section describes the device for restorative dental procedures (fillings, sealants, core build-ups), which are treatments, not diagnostic processes.
No
The provided text describes the intended use of a dental restorative material, which is a physical substance, not a software-only medical device.
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's application in dental procedures (restorations, fillings, sealants, etc.). These are procedures performed directly on the patient's teeth, not on samples taken from the patient's body for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health condition
- Using reagents or assays
The device appears to be a dental material used for restorative and protective purposes.
N/A
Intended Use / Indications for Use
Minimal Class I, II and III restorations. Class V restorations, deciduous teeth and geriatric restorations, core build-ups, root surface restorations, used as a base or liner, pit and fissure sealant, semi-permanent fillings.
Product codes
EMA, EBF, EBC
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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
§ 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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement around an emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.
JUN 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ray Cahill Director, Sales and Marketing Southern Dental Industries, Incorporated 5-9 Brunsdon Street Bayswater, P.O. Box 314 Victoria 3153 AUSTRALIA
Re: K050870
Trade/Device Name: Riva Light Cure Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Codes: EMA, EBF, and EBC Dated: May 16, 2005 Received: May 20, 2005
Dear Mr. Cahill:
We have reviewed your Section 510(k) premarket notification of intent to market the devices indicati We have reviewed your Section 510(x) prematics is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce use stated in the enclosure) to legally maneed procaded Device Amendments, or to devices that prior to May 28, 1970, the chacinent date of the Federal Food. Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal (PMA) - You may have been reclassified in accordance with the provisions of the Act. The general Act (Act) that do not require approval or a provisions of the Act. The general therefore, market the device, subject to the general secure , and advicestion controls provisions of the Act morade requiritions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (Scc above) mice existing major regulations affecting your device can be may be subject to such additional controls. "Existing 800 to 899. In addition, FDA may publish found in the Sour of Courserning your device in the Federal Register.
1
Page 2 - Mr. Ray Cahill
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 loase be advisod mar 1 27 r i setual that your device complies with other requirements of the Act or that I Dri has muces and regulations administered by other Federal agencies. You must comply with all 1 cooline statutes and 10 general mited to: registration and listing (21 CFR Part 807); an the Act 3 requirements) ; good manufacturing practice requirements as set forth in the quality iabeling (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) I mis letter will and w yours of substantial equivalence of your device to a legally premaince notinetable 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 If you don't be office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general international on your 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,
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
2
20 50 8 70
510(k) Number (if known): [LO SO & ZO
Device Name:
Riva Light Cure
Indications For Use:
Minimal Class I, Il and Illrestorations. Class V restorations, deciduous teeth and geriatric restorations, core build-ups, root surface restorations, used as a base or liner, pit and fissure sealant, semi-permanent fillings.
(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 Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K050570 |
|---|---|
| Prescription Use: | ✓ (Per 21 CFR 801.109) |
| Over-The-Counter Use: | _________________ (Optional Format 1-2-96) |