(158 days)
The Bi-Directional Spiral & Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.
The subiect device is an obturation system for filling straight and minimally curved canals. The bi-directional spiral and epoxy root canal cement, combined with a single point technique, creates a seal equivalent to lateral condensation and thermoplastic gutta percha. Contained in the kit are the following:
4 - Color Coded to ISO Size 25 Bi-Directional Spirals (1-21 mm length and 3-25 mm length) 7.5 gm - Epoxy Root Canal Cement Gel 8.0 gm - Powder (Epoxy Root Canal Cement) 1 Measuring Scoop
Here's an analysis of the provided text regarding acceptance criteria and the supporting study:
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria through extensive clinical trials. Therefore, the device's "acceptance criteria" are primarily based on meeting existing industry standards for physical properties and biocompatibility, as compared to its predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| Physical Properties (ADA Spec No. 57 / ISO 6876): | |
| - Flow | Meets/Exceeds ADA Spec No. 57 / ISO 6876 |
| - Film Thickness | Meets/Exceeds ADA Spec No. 57 / ISO 6876 |
| - Dimensional Stability | Meets/Exceeds ADA Spec No. 57 / ISO 6876 |
| - Solubility | Meets/Exceeds ADA Spec No. 57 / ISO 6876 |
| - Disintegration | Meets/Exceeds ADA Spec No. 57 / ISO 6876 |
| Biocompatibility: | Evidence does not raise new safety/biocompatibility concerns compared to predicate devices. |
| Radiopacity: | Uses silver as the primary radiopaquing agent (similar to predicate AH-26®). |
| Setting Time: | Compatible with predicate devices (AH® PLUS® and AH-26® Root Canal Sealers). |
| Shrinkage: | Compatible with predicate devices (AH® PLUS® and AH-26® Root Canal Sealers). |
| Microleakage: | Compatible with predicate devices (AH® PLUS® and AH-26® Root Canal Sealers). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of a clinical trial with a defined sample size for human subjects. The evaluation relies primarily on bench testing for physical properties and literature review for biocompatibility.
- Bench Testing: The sample sizes for each specific physical property test (flow, film thickness, etc.) are not explicitly stated. These are typically performed in a laboratory setting.
- Data Provenance: The bench testing would be conducted within a laboratory environment, likely within the submitter's (MDS) facilities or a contracted testing lab. The literature review for biocompatibility is retrospective, drawing upon existing published data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of a clinical test set for this submission. Ground truth for the bench tests would be the established methods and results defined by ADA Specification No. 57 and ISO 6876.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring expert 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. This device is a root canal cement system, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used
- For physical properties: Ground truth is established by the specified standards (ADA Specification No. 57 and ISO 6876 for Dental Root Canal Filling Material). Compliance with these standards serves as the "ground truth" for acceptable physical performance.
- For biocompatibility: Ground truth is established through existing scientific literature and Material Safety Data Sheets (MSDS) for the components, demonstrating a lack of new safety concerns compared to predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the machine learning sense. The formulation and design are based on established dental material science and the characteristics of the predicate device (AH-26®).
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no concept of "ground truth for a training set" for this type of device submission. The design and performance targets are derived from well-understood material properties and the successful history of similar predicate devices.
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JAN 1 8 2000
510(K) SUMMARY
This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is: _______________________________________________________________________________________________________________________________________________
1. Submitter's Identification:
MDS 119 West 57th Street Suite 700 New York, NY 10019
Date Summary Prepared: August 4, 1999
Contact: Dr. Barry Lee Musikant
2. Name of the Device:
Bi-Directional Spiral & Epoxy Root Canal Cement System
3. Predicate Device Information:
- AH-26® Root Canal Sealer (Pre-Amendment Device)
-
- AH® PLUS® Root Canal Sealer, K# 960548, Dentsply International, York, PA
4. Device Description:
The subiect device is an obturation system for filling straight and minimally curved canals. The bi-directional spiral and epoxy root canal cement, combined with a single point technique, creates a seal equivalent to lateral condensation and thermoplastic gutta percha. Contained in the kit are the following:
4 - Color Coded to ISO Size 25 Bi-Directional Spirals (1-21 mm length and 3-25 mm length) 7.5 gm - Epoxy Root Canal Cement Gel 8.0 gm - Powder (Epoxy Root Canal Cement) 1 Measuring Scoop
5. Intended Use:
The Bi-Directional Spiral & Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.
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6. Comparison to Predicate Devices:
The Bi-Directional Spiral & Epoxy Root Canal Cement System and its predicates are all endodontic sealing cements containing two-component systems. The AH® PLUS® Root Canal Sealer is a two-paste system (Paste A is an epoxy resin paste and Paste B is amine-containing paste), whereas the AH-26® and subject device endodontic cements are based on a powder-liquid mix. All device' two-component systems react via an epoxide/amine reaction to cause setting, and thus used in conjunction with the same auxillary materials in the root canal (i.e., gutta percha points).
The subject device is a derivative of AH-26® (a well-know epoxy-resin cement that has been reported favorably in the dental literature for more than 45 years). The subject device is noneugenol-based (no incompatibility with subsequent resin restoration procedures). Both the AH-26® and subject device use silver as the primary radiopaquing agent and a bisphenol epoxy resin as the liquid/gel. The powder and liguid systems of both AH-26® and subject device filling cement allows the clinician to choose the viscosity of the material. The AH® PLUS® Root Canal Sealer and AH-26® Root Canal Sealer are compatable in setting time, flow, shrinkage and microleakage physical property values. The difference between the subject device and the AH-26® device is that subject device uses a bi-directional spiral technique that thoroughly coats the walls of the canal without letting any cement flow beyond the apex during the application process.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Bench Testing performed on the components (contained in the kit) of the Epoxy Root Canal Cement meet/exceed ADA Specification No.57 ISO 6876 (Dental Root Canal Filling Material) and (Endodontic Filling Materials) to include physical properties such as flow, film thickness, dimensional stability, solubility and disintegration. Bi-Directional Spiral (reverse spiral drill) dimensional inspections are checked against approved meeting all required specifications
8. Discussion of Clinical Tests Performed:
Biocompatibility literature supplied with this 510(k) submission along with Material Safety Data Sheets, has shown that components contained in the Bi-Directional Spiral & Epoxy Root Canal Cement System, as well as in the predicate devices, do not raise any new safety/biocompatibility concerns.
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9. Conclusions:
The Bi-Directional Spiral & Epoxy Root Canal Cement System has the same intended use and similar technological characteristics as the predicate devices. Moreover, bench testing contained in this submission and clinical literature supplied demonstrate that any differencies in their technological charactertics do not raise any new questions as to safety or effectiveness. Thus, the Bi-Directional Spiral & Epoxy Root Canal Cement System is substantically equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 8 2000
MDS c/o Ms. Susan D. Goldstein-Falk Official Correspondent for MDS MDI Consultants, Inc. 55 Northern Boulevard, Suite 200 Great Neck, New York 11021
Re : K992727
The Bi-Directional Spiral & Epoxy Root Canal Trade Name: Cement System Requlatory Class: II Product Code: KIF Dated: Auqust 11, 1999 Received: August 13, 1999
Dear Ms. Goldstein-Falk:
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, Druq, 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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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 Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Goldstein-Falk
obligation you might have under sections 531 through 542 of exigation devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtired in your sia equivalence of your device to a legally marketed predicate device results in a classification for your marroos 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) 594-4692. 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 Arthor by reference to 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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Exhibit B
Page 1 of of 1 1
510(k) Number (if known): K992727
Device Name: The Bi-Directional Spiral & Epoxy Root Canal Cement System
Indications For Use:
The Bi-Directional Spiral & Epoxy Root Canal Cement System is indicated for permanent sealing of root canals following established endodontic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use س (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Susan Rima
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 5 1 O(k) Number _
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.