(157 days)
- Final cementation of ceramic, composite, or metal inlays, onlays, crowns, bridges, posts, and screws.
- Final cementation of ceramic, composite, or metal restorations on implant abutments.
- Permament cementation of ceramic or composite veneers.
EDS Universal Cement is an automix, dual-curing, self-adhesive resin cement. This multi-purpose device can be used to affix a variety of ceramic, composite, or metal restorations without the aid of an etchant or bonding agent. The device is comprised of two pastes (base and catalyst) that contain dimethacrylate resins, inorqanic filler particles (60% by wt), and a photoinitiator system. The mixing ratio is roughly 1 part base to 1 part catalyst. The device is packaged in a 5 mL dualbarreled syringe and comes in three shades: translucent (white), opaque (white), and A2 (tooth colored). EDS Universal Cement provides a bond between tooth surfaces (dentin and enamel) and ceramic, composite, and metal restorations. The device provides radiopacity and is resistant to mechanical stress and water damage. EDS Universal Cement is provided non-sterile and has a shelf-life of two years.
The provided document is a 510(k) premarket notification for a dental cement (EDS Universal Cement). It does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance metrics.
However, based on the document, I can extract information related to product testing and equivalence to predicate devices, which serves a similar purpose to acceptance criteria and studies in regulatory submissions for traditional medical devices.
Here's an interpretation of the request using the available information for a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical thresholds for performance. Instead, it relies on demonstrating equivalence to a legally marketed predicate device (Unicem HM). The performance is reported through a series of tests against this predicate.
| Test Category | Acceptance Criteria (Implied by equivalence) | Reported Device Performance (EDS Universal Cement) |
|---|---|---|
| Biocompatibility | Equivalent to predicate (Unicem HM) in terms of safety. Confirmed by ISO standards. | Passed Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), Implantation (ISO 10993-6), and Genotoxicity (ISO 10993-3) testing, demonstrating safety equivalence. |
| Physical Properties / Adhesion | Equivalent to predicate (Unicem HM) in performance, particularly comparative shear bond strength to various dental surfaces. | Demonstrated performance equivalence to Unicem HM through comparative shear bond strength testing on dentin, enamel, zirconia, and lithium disilicate surfaces. (Specific numerical values/statistical comparison are not provided in this summary but were likely in the full submission). |
| Fluoride Release | (Not explicitly compared to predicate, but assessed as a characteristic) | No fluoride was released over a 7-day period when immersed in distilled water. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the individual tests (e.g., number of samples for shear bond strength, number of animals for in vivo tests). It generally refers to "samples of the subject and predicate devices."
The data provenance is not explicitly stated in terms of country of origin. The study types (biocompatibility, physical properties, adhesion) are all non-clinical in vitro or in vivo (animal) studies, not human clinical studies. Therefore, it is retrospective if the tests were performed on pre-existing batches or prospective if the tests were designed specifically for this submission. The summary does not provide this detail.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable here as these are laboratory-based non-clinical tests for a dental cement, not diagnostic or AI performance evaluation studies requiring expert ground truth. The "ground truth" for these tests would be the established scientific methods and measurements.
4. Adjudication method for the test set
Not applicable for non-clinical laboratory tests. The results are typically objectively measured according to standardized protocols (e.g., ISO standards for biocompatibility, universal testing machine for shear bond strength).
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 a dental cement, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental cement, not an AI-powered device.
7. The type of ground truth used
For biocompatibility tests, the ground truth is established by ISO (International Organization for Standardization) standards (e.g., ISO 10993 series), which define acceptable biological responses.
For physical properties and adhesion tests, the "ground truth" is measured physical and material properties derived from standardized laboratory testing methods (e.g., shear bond strength in MPa). The comparison is against the predicate device's performance under similar testing conditions.
8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a traditional medical device, not an AI/ML system.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
Essential Dental Systems, Inc. Mr. Jeffrey Wan Research and Development Manager 89 Leuning Street, Suite 8 South Hackensack, New Jersey 07606
Re: K152691
Trade/Device Name: EDS Universal Cement Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 25, 2016 Received: January 27, 2016
Dear Mr. Wan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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. 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 4 - Indications for Use
510(k) Number (if known): _ K152691
Device Name: EDS Universal Cement
Indications for Use:
-
Final cementation of ceramic, composite, or metal inlays, onlays, crowns, bridges, posts, and screws.
-
Final cementation of ceramic, composite, or metal restorations on implant abutments.
-
Permament cementation of ceramic or composite veneers.
Prescription Use X (Per 21 CFR 801 Subpart D)
OR
Over the Counter Use (Per 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Section 5 - 510(k) Summary
1. Submitter's Identification:
Essential Dental Systems 89 Leuning Street South Hackensack, NJ 07606
Date Summary Prepared: February 18, 2016
Contact: Mr. Jeffrey Wan Contact Email: jwan@edsdental.com Contact Phone #: 201-487-9090 ext. 118 Contact Fax #: 201-487-5120
2. Name of the Device:
Trade name: EDS Universal Cement Common name: Dental cement other than zinc oxide-eugenol Classification name: Dental Cement CFR Number: 872.3275 Device class: Class II Product Code: EMA
3. Predicate Device Information:
Primary predicate: Unicem HM, 3M ESPE AG, K100908 Reference predicate: CALIBRATM CEMENT, Dentsply International, K040906
4. Device Description:
EDS Universal Cement is an automix, dual-curing, self-adhesive resin cement. This multi-purpose device can be used to affix a variety of ceramic, composite, or metal restorations without the aid of an etchant or bonding agent. The device is comprised of two pastes (base and catalyst) that contain dimethacrylate resins, inorqanic filler particles (60% by wt), and a photoinitiator system. The mixing ratio is roughly 1 part base to 1 part catalyst. The device is packaged in a 5 mL dualbarreled syringe and comes in three shades: translucent (white), opaque (white), and A2 (tooth colored).
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EDS Universal Cement provides a bond between tooth surfaces (dentin and enamel) and ceramic, composite, and metal restorations. The device provides radiopacity and is resistant to mechanical stress and water damage.
EDS Universal Cement is provided non-sterile and has a shelf-life of two years.
5. Indications for Use:
-
Final cementation of ceramic, composite, or metal inlays, onlays, crowns, bridges, posts, and screws.
-
Final cementation of ceramic, composite, or metal restorations on implant abutments.
-
Permament cementation of ceramic or composite veneers.
6. Comparison to Predicate Devices:
A comparison of EDS Universal Cement and the predicate devices indicates the following similarities and differences to the devices which received 510(k) clearance:
| Proposed Device | Primary Predicate | Reference Predicate | |
|---|---|---|---|
| 510(k) | To be assigned | K100908 | K040906 |
| Device Name | EDS Universal Cement | Unicem HM | Calibra™ Cement |
| Manufacturer | Essential DentalSystems | 3M ESPE | Dentsply International |
| Indicationsfor Use | - Final cementation ofceramic, composite, ormetal inlays, onlays,crowns, bridges, posts,and screws.- Final cementation ofceramic, composite, ormetal restorations onimplant abutments.- Permanentcementation of ceramicor composite veneers. | - Final cementation ofceramic, composite ormetal inlays, onlays,crowns, bridges, 2-3-unitMaryland bridges and 3-unitinlay/onlay bridges(excluded for patients withbruxismor periodontitis).- Final cementation of postand screws.- Final cementation ofceramic, composite ormetal restorations onimplant abutments.- Cementation of abutmentsmade of Lava™ zirconiumoxide ceramic. | - Adhesive cementation ofceramic, porcelain, orcomposite inlays/onlays,veneers, or crowns.- Adhesive cementation of allmetal crowns, bridges,inlays/onlays includingprecious, semi-precious, andnon-precious metals.- Adhesive cementation ofPFM (porcelain fused tometal) crowns and bridges.- Adhesive cementation ofprefabricated and cast posts.- Adhesive cementation ofresin-bonded retainerbridges (Maryland bridges) |
| Composition | Methacrylate resins andinorganic filler | Methacrylate resins andinorganic filler | Methacrylate resins andinorganic filler |
| Shades | Translucent, opaque(white), A2 | Translucent, A2, A3 opaque | Translucent, light, medium,opaque, bleach |
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EDS Universal Cement is similar to the predicate devices Unicem HM and Calibra™ in that they are all automix, self-adhesive, dual-curing resin cements intended for ceramic, composite, or metal restorations. All devices are paste/paste systems with similar filler ratios. EDS Universal Cement is also similar to Calibra™ in that they are intended for the cementation of veneers.
EDS Universal Cement is different from the predicate devices in the number and type of shades available. EDS Universal Cement is also different from Unicem HM in that Unicem HM does not have an intended use for the cementation of veneers. The subject device and primary predicate have slightly different Indications for Use language. However, the difference in language does not change the intended use or substantial equivalence.
All of the components found in the predicate devices have been used in legally marketed devices. We believe that prior use of components in legally marketed devices, the performance and biocompatibility data provided support the substantial equivalence of EDS Universal Cement for the indicated uses.
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows:
Testing of biocompatibility, physical properties, and adhesion to dentin and ceramic surfaces were conducted to determine equivalence of EDS Universal Cement to the predicate device Unicem HM.
Equivalence in safety to the predicate device was demonstrated by conducting four biocompatibility tests:
- Cytotoxicity testing according to ISO 10993-5
- Sensitization testing according to ISO 10993-10
- Implantation testing according to ISO 10993-6
- Genotoxicity testing according to ISO 10993-3
Equivalence in performance to the predicate device was demonstrated by conducting comparative shear bond strength testing to natural tooth structure and various crown materials.
Samples of the subject and predicate devices were cured onto dentin, enamel, zirconia, and lithium disilicate surfaces. Shear loading was applied at the cement-surface interface until debonding occurred.
Fluoride release testing was conducted on the subject device to determine its fluoride release profile.
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Samples of the subject device were immersed in distilled water. The fluoride concentration was measured at 1, 3, and 7 days. No fluoride was released over a 7 day period.
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Conclusions:
EDS Universal Cement is substantially equivalent to the cleared and marketed predicate device Unicem HM.
§ 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.