(80 days)
Ketac-Fil® Aplicap® Plus is a glass ionomer cement material indicated for the following uses: (1) fillings of Black Classes III and V cavities; (2) wedge-shaped defects; (3) fissure sealing; (4) small Black Class I cavities: (5) deciduous teeth; and (6) core build-ups.
Ketac-Fil® Aplicap® Plus is a modified glass ionomer cement material. Modifications have been made to the following ESPE 510(k)s for glass ionomer cement material: (1) Photac-Fil® Aplicap® (K925027); and (2) Ketac-Molar® Aplicap® (K960954), to create a slightly modified product with two new pigments.
This 510(k) summary describes a modified glass ionomer cement material, Ketac-Fil® Aplicap® Plus, which is a dental material and not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, ground truth establishment, expert adjudication, and MRMC studies, are not applicable.
Here's an analysis based on the provided text, focusing on the available information for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (if quantifiable) | Reported Device Performance (if quantifiable) |
|---|---|---|
| Material Properties | Meets requirements of relevant DIN and ISO standards for dental cement. | Ketac-Fil® Aplicap® Plus meets the requirements of relevant DIN and ISO standards for dental cement. (Implies satisfactory performance for properties like compressive strength, flexural strength, wear resistance, etc., as per standards). |
| Biocompatibility | Acceptable results for cytotoxicity, mutagenicity, eye irritation, skin irritation, sensitization, and acute oral toxicity. | Cytotoxicity, mutagenicity, eye irritation, skin irritation, sensitization, and acute oral toxicity tests have been conducted, and results are provided (and implicitly found acceptable, leading to clearance). |
| Equivalence to Predicates | Substantially similar intended uses and material composition (powder ingredients similar with slight modifications, liquid portion identical). | Ketac-Fil® Aplicap® Plus and Photac-Fil® Aplicap® have substantially similar intended uses and similar powder ingredients (except for a slightly modified silicate glass and new pigments). Ketac-Fil® Aplicap® Plus and Ketac-Molar® Aplicap® have similar intended uses and identical liquid portions. |
| Aesthetics/Translucency | New pigments provide better translucency and improved aesthetics. | Reason for modification is "to provide the user of conventional glass ionomer cement products with additional cement shade options of better translucency and improved aesthetics." (This is a design goal, and the clearance implies it was achieved to a satisfactory degree). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable. This submission is for a physical material (dental cement), not an AI/ML device involving test sets of data. The "tests" refer to physical, chemical, and biological laboratory testing of the material itself.
- The tests were conducted by ESPE in Germany.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable. This is not an AI/ML device where "ground truth" is established by human experts on a dataset. The "ground truth" in this context would be objective measurements from laboratory tests and compliance with recognized standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of data (e.g., medical images) in AI/ML studies. For a dental cement, acceptance is based on predefined physical, chemical, and biological test outcomes against specified standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device, and no human "readers" or diagnostic tasks are involved in its primary function that would necessitate an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" for demonstrating substantial equivalence and safety/effectiveness relies on:
- Objective laboratory measurements: Physical properties (e.g., relevant to DIN/ISO standards), chemical composition, and biocompatibility assays (cytotoxicity, mutagenicity, etc.).
- Compliance with recognized standards: Adherence to DIN and ISO standards for dental cement.
- Comparison to predicate devices: Demonstrating similar performance and characteristics to already cleared devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
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KA73262
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
ESPE is submitting a 510(k) premarket notification for its modified glass ionomer cement material, Ketac-Fil® Aplicap® Plus. Modifications have been made to the following ESPE 510(k)s for glass ionomer cement material: (1) Photac-Fil® Aplicap® (K925027); and (2) Ketac-Molar® Aplicap® (K960954), to create a slightly modified product with two new pigments. The reason for this modification is to provide the user of conventional glass ionomer cement products with additional cement shade options of better translucency and improved aesthetics. Ketac-Fi10 Aplicap® Plus is a glass ionomer cement material indicated for the following uses: (1) fillings of Black Classes III and V cavities; (2) wedge-shaped defects; (3) fissure sealing; (4) small Black Class I cavities: (5) deciduous teeth; and (6) core build-ups.
ESPE is claiming substantial equivalence to its previously cleared Photac-Fil® Aplicap® and Ketac-Molar® Aplicap® products. Ketac-Fil® Aplicap® Plus and Photac-Fil® Aplicap® have substantially similar intended uses, and the ingredients of the powder portion of the products are similar, except for a slightly modified silicate glass, and the addition of two new pigments. Ketac-Fil® Aplicap® Plus and Ketac-Molar® Aplicap® have similar intended uses, and the liquid portion of the products are identical.
To support substantial equivalence to predicate products, the physical and technical characteristics of Ketac-Fil® Aplicap® Plus have been compared to those of Photac-Fil® Aplicap® and Ketac-Molar® Aplicap® In addition, certain tests have been conducted on Ketac-Fil®
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Aplicap® Plus to confirm safe use of the modified silicate glass and new pigments used. Cytotoxicity, mutagenicity, eye irritation, skin irritation, sensitization, and acute oral toxicity tests have been conducted, and results are provided.
Ketac-Fil® Aplicap® Plus meets the requirements of relevant DIN and ISO standards for dental cement.
ESPE's 510(k) has been submitted on August 29, 1997 by Dr. Barbara Wagner-Schuh, at Am Griesberg 2, D-82229 Seefeld, Germany (011-49-8152-700395).
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Barbara Wagner-Schuh Regulatory Affairs ESPE GMBH & Company KG AM Griesberg 2 Seefeld, OBB., Germany
NOV 17 1997
Re : K973262 Ketac-Fil® Aplicap® Plus Trade Name: Requlatory Class: II Product Code: EMA Dated: November 7, 1997 Received: November 12, 1997
Dear Dr. Wagner-Schuh:
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 reqistration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ದ 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 regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
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Page 2 - Dr. Wagner-Schuh
not affect any obligation you might have under sections 531 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 beqin 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
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STATEMENT OF INDICATIONS FOR USE K973262
OR
Device Name: Ketac-Fil® Aplicap® Plus
Indications for use:
- Fillings of Black Classes III and V cavities ●
- Wedge-shaped defects ●
- Fissure sealing �
:
- Small Black Class I cavities .
- . Deciduous teeth
- & Core build-ups
۰۰ ۲۰
Prescription Use X
(Division Sign-Off)
Division of Dental Infection Control.
Division of Dental, Infection Control, and General Hospital Devi 510(k) Number
Over-The-Counter Use No
§ 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.