(50 days)
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No
The summary describes a dental cement and does not mention any AI or ML capabilities.
No
The device is a cementing system for dental restorations and fillings, not designed to treat a disease or condition.
No
Explanation: The device, Trionomer, is described as a resin reinforced glass ionomer cementation system used for various luting and filling purposes. Its intended uses are for bonding and restorative procedures, not for identifying or characterizing diseases or medical conditions.
No
The device description explicitly states it is a "resin reinforced glass ionomer cementation system," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Trionomer's Intended Use: The intended uses of Trionomer are all related to direct application within the mouth for dental procedures (luting crowns, bridges, posts, orthodontic appliances, fillings, cavity liners). It is used to physically bond or fill structures within the tooth or mouth.
- Lack of Specimen Examination: There is no mention of Trionomer being used to examine specimens derived from the human body. It is a material applied directly to the patient.
Therefore, Trionomer falls under the category of a dental device used for restorative and prosthetic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Trionomer is a resin reinforced glass ionomer cementation system used for the following:
- Luting porcelain-fused-to-metal crowns and bridges to tooth structure, amalgam, . composite or glass ionomer core buildings;
- . Luting metal inlays, onlays or crowns;
- . Luting pre-fabricated and cast posts;
- . Luting orthodontic appliances;
- Luting crowns made with all-alumina or all zirconia cores or other ceramic restorations ● recommending using conventional cements;
- . Cavity liners;
- Primary teeth cavity fillings; ●
- Non-stress bearing restorations such as class V fillings.
Product codes
EMA
Device Description
Trionomer is a resin reinforced glass ionomer cementation system.
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
Tooth structure
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)
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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
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§ 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
K022)50
Trionomer is a resin reinforced glass ionomer cementation system used for the following:
- Luting porcelain-fused-to-metal crowns and bridges to tooth structure, amalgam, . composite or glass ionomer core buildings;
- . Luting metal inlays, onlays or crowns;
- . Luting pre-fabricated and cast posts;
- . Luting orthodontic appliances;
- Luting crowns made with all-alumina or all zirconia cores or other ceramic restorations ● recommending using conventional cements;
- . Cavity liners;
- Primary teeth cavity fillings; ●
Non-stress bearing restorations such as class V fillings.
1
Image /page/1/Picture/2 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 top half of the circle. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2002
Pentron Clinical Technologies, LLC C/O Ms. Annmarie Tenero Pentron Laboratory Technologies, LLC 53 North Plains Industrial Road Wallingford, Connecticut 06492-0724
Re: K022150
Trade/Device Name: Trionomer Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: July 01, 2002 Received: July 02, 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 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.
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. Tenero
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, 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 Consumer Assistance at 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 vours.
Patrizia Cucurachi/for
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
5.0 INDICATION FOR USE STATEMENT
510(k) NUMBER (IF KNOWN):
DEVICE NAME: Trionomer
INDICATION FOR USE:
Trionomer is a resin reinforced glass ionomer cementation system used for the following:
- Luting porcelain-fused-to-metal crowns and bridges to tooth structure, amalgam, . composite or glass ionomer core buildings;
- Luting metal inlays, onlays or crowns; .
- Luting pre-fabricated and cast posts; ●
- Luting orthodontic appliances; .
- Luting crowns made with all-alumina or all zirconia cores or other ceramic restorations . recommending using conventional cements;
- . Cavity liners;
- Primary teeth cavity fillings; .
- Non-stress bearing restorations such as class V fillings. ●
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use / OR Over -The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Supan Grin
5.0
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number: K022150
Pentron Clinical Technologies, LLC. 510K Submission - Trionomer