(69 days)
Adhesive cementation of (all-porcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive, and threaded posts and veneers
The product is composed of powder and liquid portions.
This document describes the 510(k) summary for the Compolute® Aplicap® dental cement, focusing on its substantial equivalence to predicate devices rather than pre-market clinical study data with specific acceptance criteria. Therefore, several requested categories are not directly applicable or explicitly detailed in the provided text.
Based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (K913966, K962440, K973262, K950203, Panavia 21, Variolink II, Scotchbond Resin Cement, Nexus dental cements) in: | Demonstrated substantial equivalence in composition and indications for use. |
| - Composition | Ingredients in Compolute® Aplicap® are contained in Sono®-Cem and/or Pertac® II, with specific exceptions (strontium aluminum lanthanum fluoro silicate glass from Ketac-Fil Aplicap Plus (K973262); pigment white 6 and phosphine oxide from Protemp® Garant (K950203)). |
| - Indications for use | Comparable to Sono®-Cem, Panavia 21, Vivadent's Variolink II, 3M's Scotchbond Resin Cement, and Kerr's Nexus dental cements. |
| Compliance with DIN, ISO, and ADA standards for dental cements (Physical and Technical Characteristics) | Compolute® Aplicap® meets the requirements of DIN, ISO, and ADA standards. |
| Fluoride release data to support safe use | Fluoride release data provided. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set with a specific sample size. The primary evidence presented is a comparison against predicate devices and adherence to industry standards. This is not a study in the sense of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" here is regulatory compliance and comparison to established predicate devices and standards, not a diagnostic outcome.
4. Adjudication method for the test set
Not applicable. There is no clinical test set requiring adjudication.
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. The device is a dental cement, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a dental cement, not an algorithm.
7. The type of ground truth used
The "ground truth" for this 510(k) submission is:
- Regulatory Substantial Equivalence: Demonstrated by comparing the device's composition and intended use to previously cleared predicate devices according to FDA guidelines.
- Industry Standards: Compliance with DIN, ISO, and ADA standards for dental cements.
- Safety Data: Provision of fluoride release data.
8. The sample size for the training set
Not applicable. This is not a machine learning device; therefore, there is no training set in that context. The "training" in the regulatory sense comes from the existing knowledge base and data behind the predicate devices and industry standards.
9. How the ground truth for the training set was established
Not applicable in the context of a machine learning training set. The "ground truth" for demonstrating substantial equivalence is established through:
- Prior FDA clearances: The predicate devices (Sono®-Cem, Pertac® II, Ketac-Fil Aplicap Plus, Protemp® Garant, Panavia 21, Variolink II, Scotchbond Resin Cement, Nexus dental cements) have already undergone regulatory review and have an established safety and effectiveness profile.
- Industry consensus standards: DIN, ISO, and ADA standards represent established best practices and scientifically sound criteria for dental materials, developed and maintained by expert bodies.
- Scientific literature/data: Underlying data supporting the composition and performance characteristics of dental cements, including fluoride release.
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II. 510(K) SUMMARY OF SAFETY AND EF
FEB - 2 1998
ESPE is submitting a 510(k) premarket notification for its composite luting cement, tradenamed Compolute® Aplicap.® Compolute® Aplicap® is indicated for the adhesive cementation of (allporcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive and threaded posts, and veneers. The product is composed of powder and liquid portions.
For composition, ESPE is claiming substantial equivalence to its previously cleared dental cement Sono®-Cem (K913966) and tooth shade resin material Pertac® II (K962440). The ingredients in ESPE's Compolute® Aplicap® are contained in Sono®-Cem and/or Pertace II, with the exception of: (1) strontium aluminum lanthanum fluoro silicate glass, which is contained in ESPE's Ketac-Fil Aplicap Plus (K973262); and (2) pigment white 6 and phosphine oxide, which are contained in ESPE's Protemp® Garant temporary crown and bridge resin material (K950203). For indications, ESPE is claiming substantial equivalence to its Sono -Cem product, Kuraray Co. Ltd.'s Panavia 21, Vivadent's Variolink II, 3M's Scotchbond Resin Cement, and Kerr's Nexus dental cements, all of which have substantially similar intended uses.
To support substantial equivalence to predicate products, the physical and technical characteristics of Compolute® Aplicap® have been compared to the listed predicates. Compolute® Aplicap® meets the requirements of DIN, ISO and ADA standards for dental cements.
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To support safe use of Compolute® Aplicap®, fluoride release data have been provided on the product.
ESPE's 510(k) has been submitted on November 25, 1997, by Dr. Barbara Wagner-Schuh at ESPE Platz, D-82229 Seefeld, Germany (011-49-8152-700395).
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird-like figure, with its wings spread. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 2 1998
Dr. Barbara Wagner-Schuh Requlatory Affairs ESPE Dental-Medizin GmbH & Company, KG ESPE Plaza D-82229 Seefeld, Germany
Re : K974458 Trade Name: Compolute® Aplicap® Regulatory Class : II Product Code: EMA Dated: January 29, 1998 Received: January 29, 1998
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 3 394 1 substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. T Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. 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 regulations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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.qov/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
Compolute® Aplicap® Device Name:
Indications for use: Adhesive cementation of (all-porcelain-, composite-, and metal-) inlays, onlays, crowns, bridges, passive, and threaded posts and veneers
Susan Rusve
(Division Sign-Off) Division of Dental, Infection Control, and General Hosp 510(k) Number CA ાપ
Prescription Use X_
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
WA01A/145407.1
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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.