(70 days)
Adhesive cementation of:
-
- ceramic, porcelain, or composite inlays/onlays, veneers, or crowns;
-
- all metal crowns, bridges, inlays/onlays including precious, semi-precious, and non-precious metals;
-
- PFM (porcelain fused to metal) crowns and bridges;
-
- prefabricated and cast posts; and
-
- resin-bonded retainer bridges (Maryland bridges)
CALIBRA™ CEMENT is a visible light cured (VLC), dual-cured, or self-cured high strength cement that, with compatible dentin/enamel adhesive systems, adhesively bond and lute indirect restorations to tooth structure.
CALIBRA™ CEMENT consists of VLC base paste and catalyst paste. The base paste is mixed with the catalyst paste to form a dual-cured cement. This mixed version of the cement will self-cure or can be light-cured, or both.
CALIBRA™ CEMENT also includes a set of try-in pastes. These try-in pastes are highly water-soluble and easily rinsed away, and are used to mimic the shade of the cured cement prior to final cementation in order to ensure a good match to the adjacent dentition.
This 510(k) summary (K040906) for CALIBRA™ CEMENT describes the device and its intended use but lacks specific details regarding quantitative acceptance criteria and a detailed study report that proves the device meets those criteria.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document DOES NOT provide a table of acceptance criteria or specific quantitative performance metrics. It makes a general statement about the device's characteristics and its equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| General Statement: "We believe that the prior use of the components of CALIBRA™ CEMENT in legally marketed devices and the performance data provided support the safety and effectiveness of CALIBRA™ CEMENT for the intended uses." | |
| Technological Characteristics: "All of the components found in CALIBRA™ CEMENT have been used in legally marketed devices." | |
| Toxicity: "Because of the nearly equivalent material composition of CALIBRA™ CEMENT to the predicate device, no additional toxicity testing was necessary." |
2. Sample Size Used for the Test Set and Data Provenance:
The document DOES NOT specify any test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The approval is based on "prior use of the components" and a general statement about "performance data provided," without detailing what that data entails.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document DOES NOT mention any experts being used to establish a ground truth for a test set. This type of analysis (experts establishing ground truth) is typically associated with diagnostic or image-based devices, not material components like dental cement where performance is often measured through physical or chemical property testing.
4. Adjudication Method for the Test Set:
Not applicable, as no test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or mentioned. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is being evaluated. CALIBRA™ CEMENT is a dental cement, not a diagnostic tool requiring human interpretation in this context.
6. Standalone (Algorithm Only) Performance:
Not applicable. CALIBRA™ CEMENT is a physical material, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The performance would be related to material properties (e.g., bond strength, setting time, solubility), which are not detailed here.
7. Type of Ground Truth Used:
The document implies that the ground truth for establishing "safety and effectiveness" is based on:
- Predicate Device Equivalence: The primary basis for approval appears to be substantial equivalence to the predicate device, Enforce™ with Fluoride Cement (K940459). This suggests that the ground truth is established by the known performance and safety of legally marketed, similar devices.
- Performance Data (unspecified): The submission mentions "performance data provided," but does not explicitly state the nature of this data (e.g., in-vitro studies, mechanical testing, clinical trials, etc.) or how ground truth was established within these studies. For dental cements, ground truth is typically derived from standardized testing methods for properties like bond strength, compressive strength, film thickness, water sorption, solubility, and biocompatibility.
8. Sample Size for the Training Set:
Not applicable. As a material component (dental cement), there is no 'training set' in the context of artificial intelligence or machine learning algorithms. Its "training" would be analogous to product development and formulation testing, which are not detailed with specific sample sizes.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no 'training set' in the AI/ML sense. The "ground truth" for the material's properties would be established through standard material testing protocols and clinical evaluations over the product development lifecycle, but these details are not provided in the 510(k) summary.
In summary:
This 510(k) summary represents a premarket notification for a dental material (cement) and relies heavily on substantial equivalence to a predicate device. It does not contain the types of detailed performance study information, acceptance criteria, or ground truth methodologies typically found in submissions for diagnostic or AI-powered devices. The focus is on the known characteristics of the components and the general safety and effectiveness statement rather than presenting specific quantitative study results.
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510(k) SUMMARY
NAME & ADDRESS:
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York. PA 17404 Telefax (717) 849-4343
JUN 1 6 2004
| CONTACT: | P. Jeffery Lehn |
|---|---|
| ---------- | ----------------- |
April 2, 2004 DATE PREPARED:
TRADE OR PROPRIETARY NAME: CALIBRA™ CEMENT
Dental cement (872.3275) CLASSIFICATION NAME:
K940459 PREDICATE DEVICES: Enforce™ with Fluoride Cement
CALIBRA™ CEMENT is a visible light cured (VLC), dual-cured, DEVICE DESCRIPTION: or self-cured high strength cement that, with compatible dentin/enamel adhesive systems, adhesively bond and lute indirect restorations to tooth structure.
CALIBRA™ CEMENT consists of VLC base paste and catalyst paste. The base paste is mixed with the catalyst paste to form a dual-cured cement. This mixed version of the cement will self-cure or can be light-cured, or both.
CALIBRA™ CEMENT also includes a set of try-in pastes. These try-in pastes are highly water-soluble and easily rinsed away, and are used to mimic the shade of the cured cement prior to final cementation in order to ensure a good match to the adjacent dentition.
CALIBRA™ CEMENT is indicated for the adhesive cementation of: INTENDED USE: 1) ceramic, porcelain, or composite inlays/onlays, veneers, or crowns; 2) all metal crowns, bridges, inlays/onlays including precious, semi-precious, and non-precious metals; 3) PFM (porcelain fused to metal) crowns and bridges; 4) prefabricated and cast posts; and 5) resin-bonded retainer bridges (Maryland bridges).
TECHNOLOGICAL CHARACTERISTICS: All of the components found in CALIBRA™ CEMENT have been used in legally marketed devices.
Because of the nearly equivalent material composition of CALIBRA™ CEMENT to the predicate device, no additional toxicity testing was necessary.
We believe that the prior use of the components of CALIBRA™ CEMENT in legally marketed devices and the performance data provided support the safety and effectiveness of CALIBRA™ CEMENT for the intended uses.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 2004
Mr. P. Jeffery Lehn Ivi. I : Jeffery Loin.
Director of Corporate Compliance and Regulatory Affairs Dentsply International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
Re: K040906
Trade/Device Name: CALIBRA™ CEMENT Regulation Number: 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: April 5, 2004 Received: April 7, 2004
Dear Mr. Lehn:
・・
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section over 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Ameliuments, or to arrive Act (Act) that do not require approval of a premarket the rederal I ood, Drag, are Coou may, therefore, market the device, subject to the general approvin appression (the Act. The general controls provisions of the Act include connects 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 If your device is classinod (boo as additional controls. Existing major regulations affecting (1 MA), it may be subject to tack of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Lehn
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualled of a basedan the states with other requirements mean that FDA has made a deceminations administered by other Federal agencies. of the Act of any I cochar statutes and regarments, including, but not limited to: registration Y ou must colliply with an the Fee broquies and (1); good manufacturing practice and listing (21 CFR Part 607), laboling (21 CFR Part 820) regulation (21 CFR Part 820); and if requirements as set form in the quality of sections (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) This letter will anow you to begin mainer of substantial equivalence of your device to a premiarket notification. The PDF Imaling or 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), If you desire specific advice to: Jour de at (301) 594-4613. Also, please note the regulation prease contact the Office or Ochipments premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Inay obtain other general meetirs, International and Consumer Assistance at its toll-free DIVIsion 01.Binan 2041 or (301) 443-6597 or at its Internet address
Sincerely yours,
Kein Muluy
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
K040906 510(K) Number (if known):
Device Name:
CALIBRA™ CEMENT
Indications for Use:
Adhesive cementation of:
-
- ceramic, porcelain, or composite inlays/onlays, veneers, or crowns;
-
- Ccraine, porcenain, or componys including precious, semi-precious, and non-precious metals;
-
- PFM (porcelain fused to metal) crowns and bridges;
-
- prefabricated and cast posts; and
-
- resin-bonded retainer bridges (Maryland bridges)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
Conc
AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| urrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| ---------------------------------------------------- |
Suann Rurke
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: K
Premarket Notification
§ 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.